The following data is part of a premarket notification filed by Nanowear Inc. with the FDA for Simplecg.
| Device ID | K161431 |
| 510k Number | K161431 |
| Device Name: | SimplECG |
| 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 CENTER St Louis, MO 63011 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-24 |
| Decision Date | 2016-11-30 |
| Summary: | summary |