The following data is part of a premarket notification filed by Ascot Technologies, Inc. with the FDA for Ascot Home Medical Monitoring System (hmms).
| Device ID | K103643 |
| 510k Number | K103643 |
| Device Name: | ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | ASCOT TECHNOLOGIES, INC. 267 HOGANS VALLEY WAY Cary, NC 27513 |
| Contact | Mary E Randall |
| Correspondent | Mary E Randall ASCOT TECHNOLOGIES, INC. 267 HOGANS VALLEY WAY Cary, NC 27513 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-13 |
| Decision Date | 2011-10-06 |
| Summary: | summary |