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510(k) K813199

Device
SKIN TEMPERATURE SENSING VINYL STRIP
Applicant
T. G. & E. MEDICAL
510(k) number
K813199
Product code
KPD  
Decision
Substantially Equivalent (SESE)
Decision date
1982-03-05
Date received
1981-11-13
Regulation
880.2200
Classification name
Strip, Temperature, Forehead, Liquid Crystal
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
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 KPD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934941E-Z TEMP IISeven C'S, Inc.1994-07-27
K903307TEMP MARQ TEMPERATURE TREND INDICATORMarquest Medical Products, Inc.1990-08-17
K893803FEVER LINE AND FEVER LINE PLUSLiquid Crystal Sciences, Inc.1989-08-21
K864853OMNI THERM TEMPERATURE MONITOROmni Therm, Inc.1987-02-04
K850797TEMPALERT LIQUID CRYSTAL THERMOMETERMedical Frontiers, Inc.1985-04-05
K841913TEMPTREND PEDS AXILLARY TEMP. INDICATORBiosynergy, Inc.1984-11-02
K833904TEMPTREND IIBiosynergy, Inc.1983-12-27
K832651ATI FOREHEAD THERMOMETERAmerican Thermal Instruments, Inc.1983-10-04
K823221ACCA-TEMP SKIN TEMP. VINYL DISCT. G. & E. Medical1983-01-12
K821312TEMPTREND TEMPERATURE TREND INDICATORLiquid Crystal Products, Inc.1982-05-28
K820426TEMPERATURE TREND INDICATOR (TTI)Mon-A-Therm, Inc.1982-03-08
K802778LIQUID CRYSTAL THERM. 8 EVENT MONITORDjinnii Industires, Inc.1981-01-09
K802897ELECTRONIC DIGITAL THERMOMETERPhilip J. Teders1980-12-16
K790532FEVER TESTERMaddak, Inc.1979-05-29
K780580TEMPERATURE INDICATORRespiratory Care, Inc.1978-04-27

Legacy Summary#

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FDA Review#

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