The following data is part of a premarket notification filed by Rhythmedix, Llc with the FDA for Rhythmstar System.
| Device ID | K141813 |
| 510k Number | K141813 |
| Device Name: | RHYTHMSTAR SYSTEM |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | RHYTHMEDIX, LLC 5353 WAYZATA BLVD, SUITE 505 Minneapolis, MN 55416 |
| Contact | M.w.(andy) Anderson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868282000213 | K141813 | 000 |
| 00868282000206 | K141813 | 000 |
| 00868282000220 | K141813 | 000 |