RESTING EKG ELECTRODE SERIES

Electrode, Electrocardiograph

MEDTRONIC ANDOVER MEDICAL, INC.

The following data is part of a premarket notification filed by Medtronic Andover Medical, Inc. with the FDA for Resting Ekg Electrode Series.

Pre-market Notification Details

• Device ID: K910494
• 510k Number: K910494
• Device Name: RESTING EKG ELECTRODE SERIES
• Classification: Electrode, Electrocardiograph
• Applicant: MEDTRONIC ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830
• Contact: Janice M Pevide
• Correspondent: Janice M Pevide; MEDTRONIC ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830
• Product Code: DRX
• CFR Regulation Number: 870.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-02-05
• Decision Date: 1991-04-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20653405057342	K910494	000
20653405039140	K910494	000
20653405004582	K910494	000