Cleared Traditional

SYRINGEFILTER

K960928 · Arbor Technologies, Inc. · Anesthesiology
Apr 1997
Decision
393d
Days
Class 2
Risk

About This 510(k) Submission

K960928 is an FDA 510(k) clearance for the SYRINGEFILTER, a Filter, Conduction, Anesthetic (Class II — Special Controls, product code BSN), submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on April 4, 1997, 393 days after receiving the submission on March 7, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5130.

Submission Details

510(k) Number K960928 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1996
Decision Date April 04, 1997
Days to Decision 393 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSN — Filter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5130

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