The following data is part of a premarket notification filed by Fidus Medical Technology Corp. with the FDA for Rhyder Diagnostic Catheter.
| Device ID | K962307 |
| 510k Number | K962307 |
| Device Name: | RHYDER DIAGNOSTIC CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | FIDUS MEDICAL TECHNOLOGY CORP. 47929 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Ted Ormsby |
| Correspondent | Ted Ormsby FIDUS MEDICAL TECHNOLOGY CORP. 47929 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-09-17 |
| Summary: | summary |