FDA.reportPublic FDA data

510(k) K944855

Device
CHROMOPHARE
Applicant
BERCHTOLD HOLDING GMBH
510(k) number
K944855
Product code
FSY  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-19
Date received
1994-09-30
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
No

Applicant Contact#

Contact
W HILL
Address
Postfach 4052 Tuttlingen DE D-78505 D-78505

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FSY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142984Leo MinorSunnex, Inc.2014-10-29
K142076CLAVEGUARD FREEDOM SURGICAL LIGHTDickson & Dickson Healthcare (Us), Inc.2014-09-30
K140812MI-750 PROCEDURAL/MINOR SURGICAL LIGHTMedical Illumination International, Inc.2014-08-07
K132551ZF 720Umbel Corporation2014-06-30
K140930VIDA LED SURGICAL LIGHTING SYSTEM, V SERIESConvida Healthcare & Systems Corporation2014-06-09
K140461MACH LED 2MCDr. Mach GmbH & Co. KG2014-04-03
K140460MACH LED 2SCDr. Mach GmbH & Co. KG2014-04-03
K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker Communications2013-12-30
K132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems Corporation2013-11-05
K131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.2013-10-30
K122875ORICARE L2700Oricare, Inc.2012-12-18
K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KG2012-02-16
K102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg2010-10-26
K101537AIM 200, MAJOR SURGICAL LIGHTBurton Medical Products Corp.2010-09-30
K100702STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODSHuot Instruments, LLC2010-07-20

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases