The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Waterpath Scanning Option.
Device ID | K781508 |
510k Number | K781508 |
Device Name: | WATERPATH SCANNING OPTION |
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 | 1978-09-01 |
Decision Date | 1978-09-26 |