COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM

Plethysmograph, Pressure

WARREN E. COLLINS, INC.

The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Collin Body Plethysmograph Plus System.

Pre-market Notification Details

Device IDK852102
510k NumberK852102
Device Name:COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM
ClassificationPlethysmograph, Pressure
Applicant WARREN E. COLLINS, INC. 220 WOOD RD. Braintree,  MA  02184 -2408
ContactJames Tully
CorrespondentJames Tully
WARREN E. COLLINS, INC. 220 WOOD RD. Braintree,  MA  02184 -2408
Product CodeCCM  
CFR Regulation Number868.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-15
Decision Date1985-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852417003446 K852102 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.