BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D

Thermometer, Electronic, Clinical

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Bi-temp Temperature Monitor,model Tm-300d.

Pre-market Notification Details

Device IDK913082
510k NumberK913082
Device Name:BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
ClassificationThermometer, Electronic, Clinical
Applicant RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine,  CA  92614
ContactGordon Shigezawa
CorrespondentGordon Shigezawa
RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine,  CA  92614
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-23
Decision Date1991-12-11

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