OPTION PHO/SONIC B-MODE SCANNER

System, Imaging, Pulsed Echo, Ultrasonic

G.D. SEARLE AND CO.

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.

Pre-market Notification Details

Device IDK781344
510k NumberK781344
Device Name:OPTION PHO/SONIC B-MODE SCANNER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-04
Decision Date1978-08-21

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