FDA.reportPublic FDA data

510(k) K800067

Device
Vita Lamp, Model 0350
Applicant
TENSOR INDUSTRIES, INC.
510(k) number
K800067
Product code
KZF
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-08
Date received
1980-01-11
Regulation
880.6320
Classification name
Device, Medical Examination, Ac Powered
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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