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510(k) K941869

Device
Splint, Pneumatic, Arm & Splint, Pneumatic, Leg
Applicant
THE LIGHTHOUSE FOR THE BLIND, INC.
510(k) number
K941869
Product code
KZF
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-03
Date received
1994-04-18
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
RENEE OBRYCKI
Address
2501 S. Plum St. P.O. Box C-14119 Seattle WA US 98114 98114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K945507H 5100, H 5200, H 5300Rudolf Riester GmbH & Co. KG1994-12-09
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