The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Refstar Rmt External Reference Patch.
| Device ID | K042998 |
| 510k Number | K042998 |
| Device Name: | REFSTAR RMT EXTERNAL REFERENCE PATCH |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Mark O'donnell |
| Correspondent | Mark O'donnell BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835000658 | K042998 | 000 |