MARK 5 NUVO (M5C5)
FDA 510(k) clearance K032509 · decided 2004-03-18
Clearance details
- K-number
- K032509
- Device name
- MARK 5 NUVO (M5C5)
- Applicant
- Nidek Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-14
- Decision date
- 2004-03-18
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Birmingham, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator. recall (Z-1774-2012) | Nidek Medical Products Inc | 2012-06-19 |
| NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator. recall (Z-1775-2012) | Nidek Medical Products Inc | 2012-06-19 |
| NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator. recall (Z-1777-2012) | Nidek Medical Products Inc | 2012-06-19 |
| NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator. recall (Z-1779-2012) | Nidek Medical Products Inc | 2012-06-19 |
| NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator. recall (Z-1780-2012) | Nidek Medical Products Inc | 2012-06-19 |
| NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator. recall (Z-1781-2012) | Nidek Medical Products Inc | 2012-06-19 |
| NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator. recall (Z-1782-2012) | Nidek Medical Products Inc | 2012-06-19 |