FDA 510(k) · Nonin Medical
K052829: WRISTOX MODEL 3100 PULSE OXIMETER (Nonin Medical, Inc.)
Nonin Medical, Inc. received FDA 510(k) K052829 for WRISTOX MODEL 3100 PULSE OXIMETER, with a decision date of Nov 10, 2005 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K052829 |
|---|---|
| Pathway | 510(k) |
| Applicant | Nonin Medical, Inc. |
| Device name | WRISTOX MODEL 3100 PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Oct 5, 2005 |
| Decision date | Nov 10, 2005 |
| 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
Statement 510(k) Number (if known) Nonin Medical, Inc. Model 3100 WristOx® Pulse Oximeter Device Name The Nonin® Model 3100 WristOx® Pulse Oximeter is a small Indications wrist-worn device indicated for use in measuring, displaying, and for Use storing functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients during both no motion and motion conditions, and for patients who are well or poorly perfused. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ X_ Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) .toi Anesthesiology, General Hospitl ,uoon Control, Dental Devices ,, NLUmber _ JSZ
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.
- K030668 MODEL 3100 WRISTOX PULSE OXIMETER (Nonin Medical)
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.