The following data is part of a premarket notification filed by Urometrics, Inc. with the FDA for Neva System.
| Device ID | K980627 |
| 510k Number | K980627 |
| Device Name: | NEVA SYSTEM |
| Classification | Monitor, Penile Tumescence |
| Applicant | UROMETRICS, INC. 445 ETNA ST., SUITE 56 St. Paul, MN 55106 |
| Contact | Philip A Messina |
| Correspondent | Philip A Messina UROMETRICS, INC. 445 ETNA ST., SUITE 56 St. Paul, MN 55106 |
| Product Code | LIL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-18 |
| Decision Date | 1998-04-07 |
| Summary: | summary |