The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Modification Of The Ibi-1100 Steerable Electrophysiology Catheter System.
| Device ID | K982232 |
| 510k Number | K982232 |
| Device Name: | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine, CA 92612 |
| Contact | Roger Tu |
| Correspondent | Roger Tu 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 | 1998-06-25 |
| Decision Date | 1998-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734304658 | K982232 | 000 |
| 05414734304597 | K982232 | 000 |
| 05414734304566 | K982232 | 000 |