FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CHROMOPHARE
K Number: K965130
·
Decision Jul 14, 1997
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
16
Review Days
203
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Basic Information
- Device Name
- CHROMOPHARE
- K Number
- K965130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Berchtold Holding GmbH
- Date Received
- December 23, 1996
- Decision Date
- July 14, 1997
- Product Code
- FSY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Berchtold Holding GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K083066 | CHROMOPHARE E 778 AND E 558 | Oct 30, 2008 | Substantially Equivalent |
| K080857 | CHROMOPHARE E-SERIES | Apr 10, 2008 | Substantially Equivalent |
| K024132 | CHROMOPHARE X 65 | Mar 21, 2003 | Substantially Equivalent |
| K990656 | CHROMOPHARE D 530 LDR SURGICAL LIGHT | Jul 20, 1999 | Substantially Equivalent |
| K991527 | CHROMOPHARE D500, D530, D650 | May 27, 1999 | Substantially Equivalent |
| K974433 | CHROMOPHARE D 500, CHROMOPHARE D 530 | Feb 20, 1998 | Substantially Equivalent |
| K955750 | TELETOM | Feb 8, 1996 | Substantially Equivalent |
| K950932 | BIPOLAP HOOK ELECTRODE | Mar 15, 1995 | Substantially Equivalent |
| K944855 | CHROMOPHARE | Oct 19, 1994 | Substantially Equivalent |
| K942319 | HIRSCH BIPOLAR COAGULATION FORCEPS AND ADAPTOR CABLES | Jun 8, 1994 | Substantially Equivalent |