510(k) K963380 ยท BZC Calculator, Pulmonary Function Data
CO 2 SMO PLUS
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Aug 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring. Terminated |
BZC | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product.
Used to provide spirometric, carbon dioxide and pulse oximetry monitoring. Terminated |
BZC | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product.
Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/reco Terminated |
BZC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.