The following data is part of a premarket notification filed by Telemedcare Pty Ltd with the FDA for Telemedcare Health Monitor.
| Device ID | K103796 |
| 510k Number | K103796 |
| Device Name: | TELEMEDCARE HEALTH MONITOR |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | TELEMEDCARE PTY LTD UNIT 7, 6-8 CREWE PLACE Rosebery, New South Wales, AU 2018 |
| Contact | Steven M Moody |
| Correspondent | Steven M Moody TELEMEDCARE PTY LTD UNIT 7, 6-8 CREWE PLACE Rosebery, New South Wales, AU 2018 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-08-03 |
| Summary: | summary |