The following data is part of a premarket notification filed by Rhythmia Medical, Inc with the FDA for Rhythmia Mapping System.
| Device ID | K130750 |
| 510k Number | K130750 |
| Device Name: | RHYTHMIA MAPPING SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | RHYTHMIA MEDICAL, INC 111 SOUTH BEDFORD ST SUITE 205 Burlington, MA 01803 |
| Contact | Leon Amariglio |
| Correspondent | Leon Amariglio RHYTHMIA MEDICAL, INC 111 SOUTH BEDFORD ST SUITE 205 Burlington, MA 01803 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-19 |
| Decision Date | 2013-07-22 |
| Summary: | summary |