The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Searle Pho/sonic Alpha 2000.
Device ID | K800139 |
510k Number | K800139 |
Device Name: | SEARLE PHO/SONIC ALPHA 2000 |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-21 |
Decision Date | 1980-02-11 |