Cleared Traditional

IMPACT, MODEL 310

K820424 · Impact Instrumentation, Inc. · General Hospital
Mar 1982
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K820424 is an FDA 510(k) clearance for the IMPACT, MODEL 310, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Impact Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1982, 24 days after receiving the submission on February 16, 1982. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K820424 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1982
Decision Date March 12, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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