CHROMOPHARE D 500, CHROMOPHARE D 530
FDA 510(k) clearance K974433 · decided 1998-02-20
Clearance details
- K-number
- K974433
- Device name
- CHROMOPHARE D 500, CHROMOPHARE D 530
- Applicant
- Berchtold Holding GmbH
- Decision
- Substantially Equivalent
- Date received
- 1997-11-24
- Decision date
- 1998-02-20
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FSY
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
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| MACH LED 2SC (K140460) | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| MACH LED 2MC (K140461) | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| VISUM BLADE LED SURGICAL LIGHTING SYSTEM (K132747) | Stryker Communications | 2013-12-30 |
| VIDA LED SURGICAL LIGHTING SYSTEM (K132307) | Convida Healthcare & Systems Corporation | 2013-11-05 |
| AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (K131893) | Ajw Technology Consultants, Inc. | 2013-10-30 |
| ORICARE L2700 (K122875) | Oricare, Inc. | 2012-12-18 |
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Recalls involving this device
No recalls on record reference this clearance.