The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Ibi-1000(tm) Electrophysiology Cathter.
| Device ID | K946333 |
| 510k Number | K946333 |
| Device Name: | IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | IRVINE BIOMEDICAL, INC. 2166 MICHELSON DR. Irvine, CA 92715 |
| Contact | Peter Chen |
| Correspondent | Peter Chen IRVINE BIOMEDICAL, INC. 2166 MICHELSON DR. Irvine, CA 92715 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-29 |
| Decision Date | 1995-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734302333 | K946333 | 000 |
| 05414734301381 | K946333 | 000 |
| 05414734301350 | K946333 | 000 |
| 05414734301329 | K946333 | 000 |
| 05414734301312 | K946333 | 000 |
| 05414734301152 | K946333 | 000 |
| 05414734301145 | K946333 | 000 |
| 05414734301121 | K946333 | 000 |
| 05414734301114 | K946333 | 000 |
| 05414734300926 | K946333 | 000 |
| 05414734300896 | K946333 | 000 |
| 05414734300735 | K946333 | 000 |
| 05414734300728 | K946333 | 000 |
| 05414734300605 | K946333 | 000 |
| 05414734301398 | K946333 | 000 |
| 05414734301473 | K946333 | 000 |
| 05414734302203 | K946333 | 000 |
| 05414734302050 | K946333 | 000 |
| 05414734302012 | K946333 | 000 |
| 05414734302005 | K946333 | 000 |
| 05414734301978 | K946333 | 000 |
| 05414734301749 | K946333 | 000 |
| 05414734301626 | K946333 | 000 |
| 05414734301619 | K946333 | 000 |
| 05414734301596 | K946333 | 000 |
| 05414734301589 | K946333 | 000 |
| 05414734301534 | K946333 | 000 |
| 05414734301503 | K946333 | 000 |
| 05414734301497 | K946333 | 000 |
| 05414734300322 | K946333 | 000 |