The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for The S-vna 5-8(b) Diagnostic Ultrasound Transducer.
| Device ID | K984639 |
| 510k Number | K984639 |
| Device Name: | THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-31 |
| Decision Date | 1999-07-12 |
| Summary: | summary |