Cleared Traditional

PM3000 & PM3100 VACUUM REGULATOR

K922817 · Precision Medical, Inc. · General Hospital
Mar 1993
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K922817 is an FDA 510(k) clearance for the PM3000 & PM3100 VACUUM REGULATOR, a Regulator, Vacuum (Class II — Special Controls, product code KDP), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on March 4, 1993, 266 days after receiving the submission on June 11, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K922817 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1992
Decision Date March 04, 1993
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KDP — Regulator, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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