SimpleSENSE

Transmitters And Receivers, Electrocardiograph, Telephone

Nanowear Inc.

The following data is part of a premarket notification filed by Nanowear Inc. with the FDA for Simplesense.

Pre-market Notification Details

• Device ID: K201669
• 510k Number: K201669
• Device Name: SimpleSENSE
• Classification: Transmitters And Receivers, Electrocardiograph, Telephone
• Applicant: Nanowear Inc. 53 Boerum Place, Suite 3F Brooklyn, NY 11201
• Contact: Venkatesh Varadan
• Correspondent: Melissa Walker; Graematter, Inc. 1324 Clarkson Clayton Ctr, #332 St Louis, MO 63011
• Product Code: DXH
• Subsequent Product Code: BZQ
• Subsequent Product Code: DPS
• Subsequent Product Code: DQD
• Subsequent Product Code: DSB
• CFR Regulation Number: 870.2920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-19
• Decision Date: 2020-11-06