ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T

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 Esophageal/rectal Temperature Probe W/type T.

Pre-market Notification Details

Device IDK864044
510k NumberK864044
Device Name:ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T
ClassificationThermometer, Electronic, Clinical
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 CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-16
Decision Date1986-11-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10695085000396 K864044 000

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