The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Volusion Small Parts Transducer, Model S-vnw 5-10, Volusion Abdominal Transducer, Model S-vaw 4-7.
| Device ID | K992155 |
| 510k Number | K992155 |
| Device Name: | VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Contact | Michaela Mahl |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-06-25 |
| Decision Date | 1999-07-08 |
| Summary: | summary |