510(k) K893643 ยท DQA Oximeter
NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Oct 26, 1989 |
| Received | May 15, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. 515B 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. French 100-120V 515B 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 515B with RS-232 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. Spanish 100-120V 515B 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. 515B 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 |
| Apr 8, 2010 | Philips Healthcare Inc. 515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.