510(k) K032949 ยท DQA Oximeter
SPOT CHECK PULSE OXIMETER,512/513
| Applicant | Respironics Novametrix, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Aug 23, 2004 |
| Received | Sep 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032949
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2010 | Dixtal Medical, Inc. Dixtal Handheld Pulse Oximetry Model 513
Catalog Number: 9300-00 Terminated |
DQA | None listed |
| Dec 9, 2010 | Dixtal Medical, Inc. Dixtal Handheld Pulse Oximetry Model 512
Catalog Number: 9100-00 Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.