Cleared Traditional

K894295 - ASTRO-MED ASC-951 PRESSURE PROCESSOR
(FDA 510(k) Clearance)

Jan 1990
Decision
209d
Days
Class 2
Risk

K894295 is an FDA 510(k) clearance for the ASTRO-MED ASC-951 PRESSURE PROCESSOR. This device is classified as a Amplifier And Signal Conditioner, Transducer Signal (Class II - Special Controls, product code DRQ).

Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on January 18, 1990, 209 days after receiving the submission on June 23, 1989.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2060.

Submission Details

510(k) Number K894295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1989
Decision Date January 18, 1990
Days to Decision 209 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DRQ — Amplifier And Signal Conditioner, Transducer Signal
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2060

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