FDA 510(k) · Shenzhen Lepu Intelligent Medical Equipment
K202776: Fingertip pulse oximeter (Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.)
Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. received FDA 510(k) K202776 for Fingertip pulse oximeter, with a decision date of Mar 1, 2021 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K202776 |
|---|---|
| Pathway | 510(k) |
| Applicant | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. |
| Device name | Fingertip pulse oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 21, 2020 |
| Decision date | Mar 1, 2021 |
| 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
The Fingertip pulse oximeter is a handheld non-invasive device intended for spot- checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities, and homecare. 5.7.
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.
- K161560 Fingertip Pulse Oximeter MD300CN310 (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.