Cleared Traditional

K950477 - DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
(FDA 510(k) Clearance)

K950477 · Nikomed U.S.A., Inc. · Cardiovascular

Nov 1995

Decision

276d

Days

Class 2

Risk

K950477 is an FDA 510(k) clearance for the DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Nikomed U.S.A., Inc. (Doylestown, US). The FDA issued a Cleared decision on November 6, 1995, 276 days after receiving the submission on February 3, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number	K950477 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 1995
Decision Date	November 06, 1995
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement