The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Combison 301 Pw Ultrasound System And Transducers.
| Device ID | K002491 |
| 510k Number | K002491 |
| Device Name: | COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON CO., LTD. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Contact | Gary J Allsebrook |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2000-08-25 |