The following data is part of a premarket notification filed by Scottcare Corporation with the FDA for Telesentry, Model Ts01.
| Device ID | K092947 |
| 510k Number | K092947 |
| Device Name: | TELESENTRY, MODEL TS01 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland, OH 44135 |
| Contact | Timothy J Leyva |
| Correspondent | Timothy J Leyva SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland, OH 44135 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-24 |
| Decision Date | 2010-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856298006121 | K092947 | 000 |
| 00856298006046 | K092947 | 000 |