Cleared Traditional

K911257 - MR-5200 FULL DISCLOSURE SYSTEM
(FDA 510(k) Clearance)

K911257 · Mennen Medical, Inc. · Cardiovascular device

Aug 1991

Decision

151d

Days

Class 2

Risk

K911257 is an FDA 510(k) clearance for the MR-5200 FULL DISCLOSURE SYSTEM. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).

Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on August 19, 1991, 151 days after receiving the submission on March 21, 1991.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K911257 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 21, 1991
Decision Date	August 19, 1991
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—