ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE

Thermometer, Electronic, Clinical

HUMAN TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Human Technologies, Inc. with the FDA for Accutemp(tm) Temp. Monitioring System Swallowable.

Pre-market Notification Details

Device IDK880639
510k NumberK880639
Device Name:ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE
ClassificationThermometer, Electronic, Clinical
Applicant HUMAN TECHNOLOGIES, INC. 300 THIRD AVENUE N. St Petersburg,  FL  33701
ContactMichael Hazel
CorrespondentMichael Hazel
HUMAN TECHNOLOGIES, INC. 300 THIRD AVENUE N. St Petersburg,  FL  33701
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-16
Decision Date1988-11-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857414006032 K880639 000
00857414006025 K880639 000
00857414006018 K880639 000
00857414006001 K880639 000
00857414006049 K880639 000

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