Cleared Traditional

AS/3 PRESSURE TEMPERATURE MODULE, M-PT

K943457 · Datex Division Instrumentarium Corp. · Cardiovascular
Jul 1994
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K943457 is an FDA 510(k) clearance for the AS/3 PRESSURE TEMPERATURE MODULE, M-PT, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by Datex Division Instrumentarium Corp. (Helsinki, FI). The FDA issued a Cleared decision on July 27, 1994, 9 days after receiving the submission on July 18, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number K943457 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 1994
Decision Date July 27, 1994
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSK — Computer, Blood-pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1110

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