The following data is part of a premarket notification filed by Vitls Inc. with the FDA for Vitls Platform.
| Device ID | K191620 |
| 510k Number | K191620 |
| Device Name: | Vitls Platform |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Vitls Inc. TMC Innovation Institute, Suite X, 2450 Holcombe Blvd. Houston, TX 77021 |
| Contact | Werner Vorster |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2020-06-01 |