Chromophare
FDA 510(k) K935832 · Berchtold Holding GmbH
510(k) numberK935832
Submission
- Device name
- Chromophare
- Applicant
- Berchtold Holding GmbH
Tuttlingen, DE - Received
- December 7, 1993
- Decision date
- February 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZF – Device, Medical Examination, Ac Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6320
- Specialty
- General Hospital
Other 510(k)s with product code KZF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954943 | NevoscopeKZF · Traditional | Nizar A. Mullani | 03/27/1996SE |
| K952835 | Welch Allyn Video EpiscopeKZF · Traditional | Welch Allyn, Inc. | 09/22/1995SE |
| K945507 | H 5100, H 5200, H 5300KZF · Traditional | Rudolf Riester GmbH & Co. KG | 12/09/1994SE |
| K941869 | Splint, Pneumatic, Arm & Splint, Pneumatic, LegKZF · Traditional | The Lighthouse For the Blind, Inc. | 08/03/1994SE |
| K936088 | Wave Fluorescent MagnifierKZF · Traditional | Burton Medical Products Corp. | 04/26/1994SE |
| K940284 | Meddev Multarray Medical Examining Light ModificationKZF · Traditional | Meddev International Corp. | 02/28/1994SE |
| K933564 | Skytron Exam LightKZF · Traditional | Skytron, Div. the Kmw Group, Inc. | 02/10/1994SE |
| K934259 | Ac-Powered Medical Examination LightKZF · Traditional | Welch Allyn, Inc. | 01/28/1994SE |
| K932719 | Ritter Model 158 and 159 Exam LightsKZF · Traditional | Midmark Corp. | 12/02/1993SE |
| K924447 | VitapenKZF · Traditional | Vitajet Corp. | 09/27/1993SE |
More from Vitajet Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K083066 | Chromophare E 778 and E 558FSY · Traditional | 10/30/2008SE |
| K080857 | Chromophare E-SeriesFSY · Traditional | 04/10/2008SE |
| K024132 | Chromophare X 65FSY · Special | 03/21/2003SE |
| K990656 | Chromophare D 530 LDR Surgical LightFSY · Traditional | 07/20/1999SE |
| K991527 | Chromophare D500, D530, D650FSY · Special | 05/27/1999SE |
| K974433 | Chromophare D 500, Chromophare D 530FSY · Traditional | 02/20/1998SE |
| K965130 | ChromophareFSY · Traditional | 07/14/1997SE |
| K955750 | TeletomFQO · Traditional | 02/08/1996SE |
| K950932 | Bipolap Hook ElectrodeGEI · Traditional | 03/15/1995SE |
| K944855 | ChromophareFSY · Traditional | 10/19/1994SE |
Questions and answers
When was Chromophare cleared by the FDA?
Chromophare (K935832) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 58 days after the submission was received.
What is the product code of K935832?
The FDA product code is KZF – Device, Medical Examination, Ac Powered, a Class I (low risk) device regulated under 21 CFR 880.6320.