EPatch

Recorder, Magnetic Tape, Medical

Braemar Manufacturing, LLC

The following data is part of a premarket notification filed by Braemar Manufacturing, Llc with the FDA for Epatch.

Pre-market Notification Details

• Device ID: K171410
• 510k Number: K171410
• Device Name: EPatch
• Classification: Recorder, Magnetic Tape, Medical
• Applicant: Braemar Manufacturing, LLC 3890 Murphy Canyon Road, Suite 100 San Diego, CA 92123
• Contact: Kent Sayler
• Correspondent: Kent Sayler; Braemar Manufacturing, LLC 3890 Murphy Canyon Road, Suite 100 San Diego, CA 92123
• Product Code: DSH
• CFR Regulation Number: 870.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-15
• Decision Date: 2018-01-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B146EP2R10	K171410	000
B146EP020	K171410	000
B146EP030	K171410	000
B146EP04	K171410	000
B146EP060	K171410	000
B146EP070	K171410	000
B146EP080	K171410	000
B146EP2010	K171410	000
B146EP2020	K171410	000
B146EP2510	K171410	000
B146EP2520	K171410	000
B146EP25R0	K171410	000