The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Urodec 500.
| Device ID | K890284 |
| 510k Number | K890284 |
| Device Name: | URODEC 500 |
| Classification | Recorder, External, Pressure, Amplifier & Transducer |
| Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Product Code | FES |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-19 |
| Decision Date | 1989-05-30 |