Cleared Traditional

MODIFIED BIOLOG

K915624 · Micromedical Industries, Ltd. · Cardiovascular
Mar 1992
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K915624 is an FDA 510(k) clearance for the MODIFIED BIOLOG, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Micromedical Industries, Ltd. (Northbrook, US). The FDA issued a Cleared decision on March 27, 1992, 113 days after receiving the submission on December 5, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K915624 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 1991
Decision Date March 27, 1992
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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