SJM CONFIRM

Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Sjm Confirm.

Pre-market Notification Details

• Device ID: K122161
• 510k Number: K122161
• Device Name: SJM CONFIRM
• Classification: Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
• Applicant: ST. JUDE MEDICAL 701 EAST EVELYN AVENUE Sunnyvale, CA 94086 -6527
• Contact: Saket Bhatt
• Correspondent: Saket Bhatt; ST. JUDE MEDICAL 701 EAST EVELYN AVENUE Sunnyvale, CA 94086 -6527
• Product Code: MXC
• CFR Regulation Number: 870.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-20
• Decision Date: 2012-11-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05414734502597	K122161	000