The following data is part of a premarket notification filed by Eris Medical Technology with the FDA for Eris Uro-diagnostic System.
| Device ID | K850169 |
| 510k Number | K850169 |
| Device Name: | ERIS URO-DIAGNOSTIC SYSTEM |
| Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Applicant | ERIS MEDICAL TECHNOLOGY 1308 SPRINGFIELD AVE. New Providence, NJ 07974 |
| Contact | David Suggs |
| Correspondent | David Suggs ERIS MEDICAL TECHNOLOGY 1308 SPRINGFIELD AVE. New Providence, NJ 07974 |
| Product Code | FFG |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-16 |
| Decision Date | 1985-04-22 |