The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Viking Diagnostic Electrode Catheter.
| Device ID | K971265 |
| 510k Number | K971265 |
| Device Name: | VIKING DIAGNOSTIC ELECTRODE CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | C.R. BARD, INC. 129 CONCORD RD. Billerica, MA 01821 |
| Contact | Anne Kulis |
| Correspondent | Anne Kulis C.R. BARD, INC. 129 CONCORD RD. Billerica, MA 01821 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-04 |
| Decision Date | 1997-10-23 |
| Summary: | summary |