MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Myocardial Temp. Sensor W/type T Thermocouple.

Pre-market Notification Details

Device IDK873206
510k NumberK873206
Device Name:MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
ClassificationMonitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Applicant RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa,  CA  92626
ContactAnthony V Beran
CorrespondentAnthony V Beran
RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa,  CA  92626
Product CodeDTW  
CFR Regulation Number870.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-14
Decision Date1987-09-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10695085000549 K873206 000
20695085000539 K873206 000
20695085000522 K873206 000

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