FDA 510(k) · Amemo
K153021: Fingertip Pulse Oximeter A310 (Amemo, Inc.)
Amemo, Inc. received FDA 510(k) K153021 for Fingertip Pulse Oximeter A310, with a decision date of Nov 22, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K153021 |
|---|---|
| Pathway | 510(k) |
| Applicant | Amemo, Inc. |
| Device name | Fingertip Pulse Oximeter A310 |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Oct 15, 2015 |
| Decision date | Nov 22, 2016 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Fingertip Pulse Oximeter A310 is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals. Device description: Fingertip Pulse Oximeter A310 is a battery powered device intended for use in III-1 AMEMO INC 1154 Cadillac Court Milpitas CA 95035 USA measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Finger Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. This equipment mainly composed of PCB board, On/Off button, mode button, OLED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device does not support the measurement in the condition of low perfusion. The device is not intended for life-supporting or life-sustaining. The device is reusable and does not need sterilization. III-2 AMEMO INC 1154 Cadillac Court Milpitas CA 95035 USA
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K093757 MD300C1 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technology)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.