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K Number
K961364

Validate with FDA (Live)

Device Name
AUTOMATIC TUBING CLAMP SYSTEM (ATC)
Manufacturer
ROCKY MOUNTAIN RESEARCH, INC.
Date Cleared
1996-10-31

(205 days)

Product Code
KRL
Regulation Number
870.4205
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K032213,K070213,K070286
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.4205 Cardiopulmonary bypass bubble detector.

(a)
Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).