AUTOMATIC TUBING CLAMP SYSTEM (ATC)

Detector, Bubble, Cardiopulmonary Bypass

ROCKY MOUNTAIN RESEARCH, INC.

The following data is part of a premarket notification filed by Rocky Mountain Research, Inc. with the FDA for Automatic Tubing Clamp System (atc).

Pre-market Notification Details

Device IDK961364
510k NumberK961364
Device Name:AUTOMATIC TUBING CLAMP SYSTEM (ATC)
ClassificationDetector, Bubble, Cardiopulmonary Bypass
Applicant ROCKY MOUNTAIN RESEARCH, INC. 825 NORTH 300 WEST, SUITE 500 Salt Lake City,  UT  84103
ContactRobert W Griffiths
CorrespondentRobert W Griffiths
ROCKY MOUNTAIN RESEARCH, INC. 825 NORTH 300 WEST, SUITE 500 Salt Lake City,  UT  84103
Product CodeKRL  
CFR Regulation Number870.4205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-09
Decision Date1996-10-31

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