Cleared Special

BLY-501 ADAPTOR

K012540 · Micromedical Industries, Ltd. · Cardiovascular
Sep 2001
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K012540 is an FDA 510(k) clearance for the BLY-501 ADAPTOR, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Micromedical Industries, Ltd. (Labrador, Queensland, AU). The FDA issued a Cleared decision on September 26, 2001, 50 days after receiving the submission on August 7, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K012540 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2001
Decision Date September 26, 2001
Days to Decision 50 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340