The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonace 2000.
Device ID | K923246 |
510k Number | K923246 |
Device Name: | SONACE 2000 |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | MEDISON CO., LTD. 5319 RANDALL PLACE Fremont, CA 94538 |
Contact | Mark Hayward |
Correspondent | Mark Hayward MEDISON CO., LTD. 5319 RANDALL PLACE Fremont, CA 94538 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-02 |
Decision Date | 1993-05-20 |