The following data is part of a premarket notification filed by Bard Electrophysiology with the FDA for Bard Plaque Electrode Array.
| Device ID | K893611 |
| 510k Number | K893611 |
| Device Name: | BARD PLAQUE ELECTRODE ARRAY |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BARD ELECTROPHYSIOLOGY 5 FEDERAL ST. P.O. BOX 5069 Billerica, MA 01822 |
| Contact | Ernest Manfredo |
| Correspondent | Ernest Manfredo BARD ELECTROPHYSIOLOGY 5 FEDERAL ST. P.O. BOX 5069 Billerica, MA 01822 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-10 |
| Decision Date | 1989-07-14 |