The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Rhythmia Hdx Mapping System.
| Device ID | K162793 |
| 510k Number | K162793 |
| Device Name: | RHYTHMIA HDx Mapping System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Boston Scientific Corporation 125 Cambridgepark Drive Suite 600 Cambridge, MA 01752 |
| Contact | Regina Holmes |
| Correspondent | Regina Holmes Boston Scientific Corporation 125 Cambridgepark Drive Suite 600 Cambridge, MA 01752 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-04 |
| Decision Date | 2017-03-10 |
| Summary: | summary |