Physiotrace

Electrode, Electrocardiograph

NimbleHeart, Inc.

The following data is part of a premarket notification filed by Nimbleheart, Inc. with the FDA for Physiotrace.

Pre-market Notification Details

• Device ID: K171244
• 510k Number: K171244
• Device Name: Physiotrace
• Classification: Electrode, Electrocardiograph
• Applicant: NimbleHeart, Inc. 1300 White Oaks Rd., Suite #201 Campbell, CA 95008
• Contact: Sonal Tambe
• Correspondent: Sonal Tambe; NimbleHeart, Inc. 1300 White Oaks Rd., Suite #201 Campbell, CA 95008
• Product Code: DRX
• Subsequent Product Code: MHX
• Subsequent Product Code: MWI
• CFR Regulation Number: 870.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-28
• Decision Date: 2017-08-23
• Summary: summary