SARNS AIR DETECTION SYSTEM

K935977 · 3M Health Care, Sarns · KRL · Feb 4, 1994 · Cardiovascular

Device Facts

Record IDK935977
Device NameSARNS AIR DETECTION SYSTEM
Applicant3M Health Care, Sarns
Product CodeKRL · Cardiovascular
Decision DateFeb 4, 1994
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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