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510(k) K945507

Device
H 5100, H 5200, H 5300
Applicant
RUDOLF RIESTER GMBH & CO. KG
510(k) number
K945507
Product code
KZF  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-09
Date received
1994-11-09
Regulation
880.6320
Classification name
Device, Medical Examination, Ac Powered
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KARLHEINZ RIESTER
Address
Postfach 35 Bruckstrabe 31 D-72417 Jungingen DE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KZF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954943NEVOSCOPENizar A. Mullani1996-03-27
K952835WELCH ALLYN VIDEO EPISCOPEWelch Allyn, Inc.1995-09-22
K941869SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEGThe Lighthouse For the Blind, Inc.1994-08-03
K936088WAVE FLUORESCENT MAGNIFIERBurton Medical Products Corp.1994-04-26
K940284MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATIONMeddev International Corp.1994-02-28
K933564SKYTRON EXAM LIGHTSkytron, Div. the Kmw Group, Inc.1994-02-10
K935832CHROMOPHAREBerchtold Holding GmbH1994-02-03
K934259AC-POWERED MEDICAL EXAMINATION LIGHTWelch Allyn, Inc.1994-01-28
K932719RITTER MODEL 158 AND 159 EXAM LIGHTSMidmark Corp.1993-12-02
K924447VITAPENVitajet Corp.1993-09-27
K931197MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHTMeddev International Corp.1993-09-23
K931645HALUX TASKLIGHTBurton Medical Products Corp.1993-08-20
K931646MI-4 VARIABLE SPOT LIGHTMedical Illumination, Inc.1993-08-19
K931026MI-5 DIAGNOSTIC LIGHTMedical Illumination, Inc.1993-08-19
K925710M.E.D. LIGHTMedical Illumination, Inc.1993-06-04

Legacy Summary#

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FDA Review#

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