MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE

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 Meditronic Andover Medical Model 1690 Electrode.

Pre-market Notification Details

• Device ID: K905446
• 510k Number: K905446
• Device Name: MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
• Classification: Electrode, Electrocardiograph
• Applicant: MEDTRONIC ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830
• Contact: Dawn E Sissom
• Correspondent: Dawn E Sissom; 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: 1990-12-05
• Decision Date: 1991-02-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20851491007177	K905446	000
20653405004193	K905446	000
20653405004223	K905446	000
20653405004209	K905446	000
20653405004186	K905446	000
20653405004230	K905446	000