The following data is part of a premarket notification filed by Cardiocom Llc with the FDA for Tablet Commander.
| Device ID | K122285 |
| 510k Number | K122285 |
| Device Name: | TABLET COMMANDER |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | CARDIOCOM LLC 7980 CENTURY BLVD. Chanhassen, MN 55317 |
| Contact | Daniel L Cosentino |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000001964 | K122285 | 000 |