The following data is part of a premarket notification filed by Comarch Healthcare Sa with the FDA for Comarch E-care Platform.
| Device ID | K181248 |
| 510k Number | K181248 |
| Device Name: | Comarch E-Care Platform |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Comarch Healthcare SA al. Jana Pawla II 39a, Krakow, PL 31-864 |
| Contact | Irmina Serafin |
| Correspondent | Jigar Shah mdi Consultants, Inc. 55 Northern Blvd, Suite 200 Great Neck, NY 11021 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-10 |
| Decision Date | 2018-10-22 |
| Summary: | summary |