The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Option Pho/sonic B-mode Scanner.
| Device ID | K781344 |
| 510k Number | K781344 |
| Device Name: | OPTION PHO/SONIC B-MODE SCANNER |
| 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 | 1978-08-04 |
| Decision Date | 1978-08-21 |