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K Number
K955010
Device Name
AUTOVAC BP SYSTE, 2000 SERIES
Manufacturer
BOEHRINGER LABORATORIES
Date Cleared
1996-06-20

(232 days)

Product Code
CAC
Regulation Number
868.5830
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).