510(k) K913516 ยท DQA Oximeter
MODEL 520A NOVAMETRIX PULSE OXIMETER
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Nov 4, 1991 |
| Received | Aug 7, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. 100-120V Oxypleth - 520A Pulse Oximeter - 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. Japanese 100-120V Oxypleth - 520A Pulse Oximeter- 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. Span 100-120V 520A - OxyPleth Pulse Oximeter - 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 Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
| Jun 28, 2009 | Dixtal Medical, Inc. Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style
Catalog #: 6480-25.
The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of t Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.