510(k) K000794 ยท DQA Oximeter
MODIFICATION TO MARSPO2, MODEL 2001
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Apr 10, 2000 |
| Received | Mar 13, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000794
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V 2001 Pulse Oximeter With Mars - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
| Jul 20, 2004 | Respironics Novametrix, Inc. Model 509M Pulse Oximetry Interface Module
Software versions 2.0 or 2.5 Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.