The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Inquiry Afocus, Inquiry Afocus Ii And Inquiry Optima Steerable Electrophysiology Catheter.
| Device ID | K042775 |
| 510k Number | K042775 |
| Device Name: | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. Irvine, CA 92614 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. Irvine, CA 92614 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2004-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734311489 | K042775 | 000 |
| 05414734311434 | K042775 | 000 |
| 05414734311427 | K042775 | 000 |
| 05414734305891 | K042775 | 000 |
| 05414734305327 | K042775 | 000 |
| 05414734305297 | K042775 | 000 |
| 05414734305174 | K042775 | 000 |
| 05414734305150 | K042775 | 000 |
| 05414734304986 | K042775 | 000 |