The following data is part of a premarket notification filed by Nanowear Inc. with the FDA for Simplesense Platform.
| Device ID | K212160 |
| 510k Number | K212160 |
| Device Name: | SimpleSENSE Platform |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | Nanowear Inc. 53 Boerum Place, Suite 3F Brooklyn, NY 11201 |
| Contact | Venkatesh Varadan |
| Correspondent | Venkatesh Varadan Nanowear Inc. 53 Boerum Place, Suite 3F Brooklyn, NY 11201 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2021-09-22 |