HANAULUX 2005 SURGICAL LIGHT
FDA 510(k) clearance K932451 · decided 1993-11-12
Clearance details
- K-number
- K932451
- Device name
- HANAULUX 2005 SURGICAL LIGHT
- Applicant
- Heraeus Instruments GmbH
- Decision
- Substantially Equivalent
- Date received
- 1993-05-20
- Decision date
- 1993-11-12
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- FTD
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hanau, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD5674 recall (Z-0768-2024) | Getinge Usa Sales Inc | 2024-01-19 |