Cleared Traditional

MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.

K900551 · Matrix Medica, Inc. · Cardiovascular
May 1990
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K900551 is an FDA 510(k) clearance for the MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC., a Transducer, Blood-pressure, Extravascular (Class II — Special Controls, product code DRS), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on May 9, 1990, 92 days after receiving the submission on February 6, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2850.

Submission Details

510(k) Number K900551 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1990
Decision Date May 09, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRS — Transducer, Blood-pressure, Extravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2850

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