510(k) K032509 ยท CAW Generator, Oxygen, Portable
MARK 5 NUVO (M5C5)
| Applicant | Nidek Medical Products, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Mar 18, 2004 |
| Received | Aug 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032509
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W.
Oxygen Concentrator. Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.