510(k) K083066
- Device
- CHROMOPHARE E 778 AND E 558
- Applicant
- BERCHTOLD HOLDING GMBH
- 510(k) number
- K083066
- Product code
- FSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-30
- Date received
- 2008-10-15
- Regulation
- 878.4580
- Classification name
- Light, Surgical, Ceiling Mounted
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- SILKE GORAL
- Address
- Ludwigstaler Strabe 25 Tuttlingen DE D-78532 D-78532
FDA Registration Numbers#
- 3009028104
- 9710098
- 3011580044
- 3012165496
- 1225473
- 1423537
- 3029970239
- 1066635
- 3031700059
- 9710055
- 3015131225
- 3011910987
- 1000122786
- 1054713
- 1836161
- 3009061550
- 3009542956
- 3030516433
- 8010153
- 3002821232
- 2031963
- 3010726901
- 1921846
- 3033527731
- 3007238566
- 9617655
- 3025628903
- 3042992004
- 9611503
- 3011644607
- 3015468226
- 1825014
- 3000286616
- 1066270
- 9710585
- 3042970964
- 3035641086
- 3027847726
- 1043572
- 3021839632
- 3006223081
- 3012272052
- 3015223105
- 3007591382
- 3009129579
- 3002532594
- 3007682310
- 9680506
- 3003574554
- 3029936435
- 3042991836
- 3011137372
- 3023808059
- 9681407
- 3026390991
- 3005698350
- 3011574775
- 3031563141
- 3012092534
- 9612030
- 3020703842
- 3017970309
- 3007143268
- 3006437518
- 3010041511
- 1017294
Source Documents#
Other 510(k) Records For Product Code FSY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142984 | Leo Minor | Sunnex, Inc. | 2014-10-29 |
| K142076 | CLAVEGUARD FREEDOM SURGICAL LIGHT | Dickson & Dickson Healthcare (Us), Inc. | 2014-09-30 |
| K140812 | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | Medical Illumination International, Inc. | 2014-08-07 |
| K132551 | ZF 720 | Umbel Corporation | 2014-06-30 |
| K140930 | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | Convida Healthcare & Systems Corporation | 2014-06-09 |
| K140461 | MACH LED 2MC | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| K140460 | MACH LED 2SC | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | Stryker Communications | 2013-12-30 |
| K132307 | VIDA LED SURGICAL LIGHTING SYSTEM | Convida Healthcare & Systems Corporation | 2013-11-05 |
| K131893 | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS | Ajw Technology Consultants, Inc. | 2013-10-30 |
| K122875 | ORICARE L2700 | Oricare, Inc. | 2012-12-18 |
| K120392 | CHROMOPHARE F 628 AND F 528 | Berchtold GmbH & Co. KG | 2012-02-16 |
| K102758 | TRULIGHT 5520 AND TRULIGHT 5320 | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2010-10-26 |
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | Burton Medical Products Corp. | 2010-09-30 |
| K100702 | STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS | Huot Instruments, LLC | 2010-07-20 |
Legacy Summary#
summary
FDA Review#
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