Cleared Traditional

IMPACT MODEL 601

K841537 · Impact Instrumentation, Inc. · Anesthesiology
May 1984
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K841537 is an FDA 510(k) clearance for the IMPACT MODEL 601, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Impact Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1984, 45 days after receiving the submission on April 16, 1984. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K841537 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1984
Decision Date May 31, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTI — Compressor, Air, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.6250