AUTOMATIC TUBING CLAMP SYSTEM (ATC)

K961364 · Rocky Mountain Research, Inc. · KRL · Oct 31, 1996 · Cardiovascular

Device Facts

Record IDK961364
Device NameAUTOMATIC TUBING CLAMP SYSTEM (ATC)
ApplicantRocky Mountain Research, Inc.
Product CodeKRL · Cardiovascular
Decision DateOct 31, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.4205
Device ClassClass 2

Regulatory Classification

Identification

A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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