The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Sa8800 Diagnostic Ultrasound System And Transducers,.
| Device ID | K974269 |
| 510k Number | K974269 |
| Device Name: | SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Contact | Peter Klein |
| Correspondent | Peter Klein MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-13 |
| Decision Date | 1998-08-21 |
| Summary: | summary |