Cleared Traditional

ASC-952 PHYSIOLOGICAL AMPLIFIER

K894735 · Astro-Med, Inc. · Cardiovascular
Sep 1989
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K894735 is an FDA 510(k) clearance for the ASC-952 PHYSIOLOGICAL AMPLIFIER, a Amplifier And Signal Conditioner, Biopotential (Class II — Special Controls, product code DRR), submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on September 18, 1989, 53 days after receiving the submission on July 27, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2050.

Submission Details

510(k) Number K894735 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1989
Decision Date September 18, 1989
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRR — Amplifier And Signal Conditioner, Biopotential
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2050

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