510(k) K890517 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
TRANSCUTANEOUS O2/CO2 MONITOR
| Applicant | Novametrix Medical Systems, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Apr 14, 1989 |
| Received | Jan 30, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Philips Healthcare Inc. Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements. Terminated |
LKD | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurement Terminated |
LKD | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Spanish 100-120V TCOM-860, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements. Terminated |
LKD | None listed |
| Apr 8, 2010 | Philips Healthcare Inc. Transcutaneous C02 & 02 Monitor - 860, Refurbished, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 Terminated |
LKD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.