The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Rhythmia Hdxtm Mapping System.
| Device ID | K192438 |
| 510k Number | K192438 |
| Device Name: | Rhythmia HDxTM Mapping System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Boston Scientific Corporation 125 Cambridgepark Drive Cambridge, MA 02140 |
| Contact | Lee Margolin |
| Correspondent | Lee Margolin Boston Scientific Corporation 125 Cambridgepark Drive 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 | 2019-09-06 |
| Decision Date | 2019-11-27 |
| Summary: | summary |