The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569.
| Device ID | K010471 |
| 510k Number | K010471 |
| Device Name: | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine, CA 92612 |
| Contact | James Farnworth |
| Correspondent | James Farnworth IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine, CA 92612 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-20 |
| Decision Date | 2001-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734305303 | K010471 | 000 |
| 05414734305273 | K010471 | 000 |
| 05414734305235 | K010471 | 000 |
| 05414734305228 | K010471 | 000 |
| 05414734305051 | K010471 | 000 |
| 05414734305020 | K010471 | 000 |
| 05414734305013 | K010471 | 000 |
| 05414734305006 | K010471 | 000 |
| 05414734304962 | K010471 | 000 |