Cleared Traditional

AUTOPRIME

K964283 · Arbor Technologies, Inc. · General Hospital
Jan 1997
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K964283 is an FDA 510(k) clearance for the AUTOPRIME, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on January 22, 1997, 86 days after receiving the submission on October 28, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K964283 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1996
Decision Date January 22, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPB — Filter, Infusion Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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