Cleared Traditional

AS/3 ESTPR MODULE

K953175 · Datex Division Instrumentarium Corp. · Cardiovascular
Feb 1997
Decision
580d
Days
Class 2
Risk

About This 510(k) Submission

K953175 is an FDA 510(k) clearance for the AS/3 ESTPR MODULE, a Monitor, St Segment With Alarm (Class II — Special Controls, product code MLD), submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on February 6, 1997, 580 days after receiving the submission on July 7, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K953175 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1995
Decision Date February 06, 1997
Days to Decision 580 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MLD — Monitor, St Segment With Alarm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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