SYNTEX SYSTEM 6000

System, X-ray, Tomography, Computed

SYNTEX CORP.

The following data is part of a premarket notification filed by Syntex Corp. with the FDA for Syntex System 6000.

Pre-market Notification Details

Device IDK761330
510k NumberK761330
Device Name:SYNTEX SYSTEM 6000
ClassificationSystem, X-ray, Tomography, Computed
Applicant SYNTEX CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-12-27
Decision Date1976-12-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.