Chromophare E 778 and E 558
FDA 510(k) K083066 · Berchtold Holding GmbH
510(k) numberK083066
Submission
- Device name
- Chromophare E 778 and E 558
- Applicant
- Berchtold Holding GmbH
Tuttlingen, DE - Received
- October 15, 2008
- Decision date
- October 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FSY – Light, Surgical, Ceiling Mounted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K142984 | Leo MinorFSY · Traditional | Sunnex, Inc. | 10/29/2014SE |
| K142076 | Claveguard Freedom Surgical LightFSY · Traditional | Dickson & Dickson Healthcare (Us), Inc. | 09/30/2014SE |
| K140812 | MI-750 Procedural/Minor Surgical LightFSY · Traditional | Medical Illumination International, Inc. | 08/07/2014SE |
| K132551 | ZF 720FSY · Traditional | Umbel Corporation | 06/30/2014SE |
| K140930 | Vida LED Surgical Lighting System, V SeriesFSY · Traditional | Convida Healthcare & Systems Corporation | 06/09/2014SE |
| K140461 | Mach LED 2MCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K140460 | Mach LED 2SCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K132747 | Visum Blade LED Surgical Lighting SystemFSY · Traditional | Stryker Communications | 12/30/2013SE |
| K132307 | Vida LED Surgical Lighting SystemFSY · Traditional | Convida Healthcare & Systems Corporation | 11/05/2013SE |
| K131893 | Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical LightsFSY · Traditional | Ajw Technology Consultants, Inc. | 10/30/2013SE |
More from Ajw Technology Consultants, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K942319 | Hirsch Bipolar Coagulation Forceps and Adaptor CablesGEI · Traditional | 06/08/1994SE |
Questions and answers
When was Chromophare E 778 and E 558 cleared by the FDA?
Chromophare E 778 and E 558 (K083066) received a 510(k) decision of Substantially Equivalent on October 30, 2008, 15 days after the submission was received.
What is the product code of K083066?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.