Cleared Traditional

AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS

K944232 · Haemonetics Corp. · Anesthesiology
Jul 1995
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K944232 is an FDA 510(k) clearance for the AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on July 20, 1995, 322 days after receiving the submission on September 1, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K944232 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1994
Decision Date July 20, 1995
Days to Decision 322 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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