MARK 5 NUVO (M5C5)— 510(k) K032509
Substantially EquivalentNidek Medical Products, Inc.
FDA 510(k) clearance K032509 for MARK 5 NUVO (M5C5), Substantially Equivalent on 2004-03-18. Applicant: Nidek Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Nidek Medical Products, Inc.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Recent devices under product code CAW
view allMore clearances from Nidek Medical Products, Inc.
view allAdverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K032509
K-number listed on FDA's recall record- Z-1774-2012 — NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
- Z-1775-2012 — NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
- Z-1777-2012 — NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
- Z-1779-2012 — NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
- Z-1780-2012 — NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
- Z-1781-2012 — NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
- Z-1782-2012 — NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032509.
Data sourced from openFDA. This site is unofficial and independent of the FDA.