Cleared Traditional

BIODAN TYPE COMET ELECTRODE

K871668 · National Medical Technology · Cardiovascular

Jun 1987

Decision

43d

Days

Class 2

Risk

About This 510(k) Submission

K871668 is an FDA 510(k) clearance for the BIODAN TYPE COMET ELECTRODE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by National Medical Technology (Quebec, Canada, CA). The FDA issued a Cleared decision on June 10, 1987, 43 days after receiving the submission on April 28, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number	K871668 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1987
Decision Date	June 10, 1987
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—