The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Rhythmia Hdx Mapping System (with Software Version 2.0).
| Device ID | K173837 |
| 510k Number | K173837 |
| Device Name: | RHYTHMIA HDx Mapping System (with Software Version 2.0) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Boston Scientific Corporation 125 Cambridgepark Drive Suite 600 Cambridge, MA 02140 |
| Contact | Gregory Neal |
| Correspondent | Gregory Neal Boston Scientific Corporation 125 Cambridgepark Drive Suite 600 Cambridge, MA 02140 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-18 |
| Decision Date | 2018-07-25 |
| Summary: | summary |