Cleared Traditional

CARDIOLAB AMPLIFIER MODULE (CAM)

K910307 · Prucka Engineering, Inc. · Cardiovascular
Apr 1991
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K910307 is an FDA 510(k) clearance for the CARDIOLAB AMPLIFIER MODULE (CAM), a Amplifier And Signal Conditioner, Biopotential (Class II — Special Controls, product code DRR), submitted by Prucka Engineering, Inc. (Houston, US). The FDA issued a Cleared decision on April 12, 1991, 78 days after receiving the submission on January 24, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2050.

Submission Details

510(k) Number K910307 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1991
Decision Date April 12, 1991
Days to Decision 78 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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