Cleared Traditional

PM9000 VAC TRAP

K941818 · Precision Medical, Inc. · General Hospital
Dec 1994
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K941818 is an FDA 510(k) clearance for the PM9000 VAC TRAP, a Bottle, Collection, Vacuum (Class II — Special Controls, product code KDQ), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on December 12, 1994, 243 days after receiving the submission on April 13, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K941818 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1994
Decision Date December 12, 1994
Days to Decision 243 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KDQ — Bottle, Collection, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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