The following data is part of a premarket notification filed by Urometrics, Inc. with the FDA for Knoll/midus (male Impotence Diagnostic Ultrasonic System).
| Device ID | K971790 |
| 510k Number | K971790 |
| Device Name: | KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | UROMETRICS, INC. 445 ETNA ST., SUITE 56 St. Paul, MN 55106 |
| Contact | Phillip A Messina |
| Correspondent | Phillip A Messina UROMETRICS, INC. 445 ETNA ST., SUITE 56 St. Paul, MN 55106 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-14 |
| Decision Date | 1997-12-17 |
| Summary: | summary |