FDA 510(k) · Nonin Medical
K030668: MODEL 3100 WRISTOX PULSE OXIMETER (Nonin Medical, Inc.)
Nonin Medical, Inc. received FDA 510(k) K030668 for MODEL 3100 WRISTOX PULSE OXIMETER, with a decision date of Oct 17, 2003 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K030668 |
|---|---|
| Pathway | 510(k) |
| Applicant | Nonin Medical, Inc. |
| Device name | MODEL 3100 WRISTOX PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Mar 3, 2003 |
| Decision date | Oct 17, 2003 |
| 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 Nonin Model 3 100 WristOxTMPulse Oximeter is a srnalI, wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterid hemoglobin (Sp02) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients in hospitals, mediczll facilities, ambulatory, subacute, and sleep study environments Concurrence of CDRH, Office of Device Evaluation 510(k) Number: KO30668
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
Later records that cite K030668
- K052829 WRISTOX MODEL 3100 PULSE OXIMETER (Nonin Medical, Nov 10, 2005, DQA)
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.