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510(k) K212160

SimpleSENSE Platform by Nanowear, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2021
Date Received
July 12, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by Nanowear, Inc.

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  • K161431 — SimplECG (November 30, 2016)

Other clearances for product code DXH

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  • K243438 — MEMO Patch M (MPT-E08R-UNC01) (December 5, 2025)
  • K243981 — Hexoskin Medical System (7100-00016) (November 18, 2025)
  • K243003 — VitalSigns 1-Lead Holter (VSH101) (June 17, 2025)
  • K233521 — QT ECG (QTERD100) (December 6, 2023)
  • K222842 — V-Patch Cardiac Monitor (October 20, 2022)
  • K220795 — QT ECG (September 26, 2022)
  • K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Puls (July 19, 2022)
  • K220350 — KardiaMobile 6L (May 25, 2022)