X-RAY, PORTABLE

System, X-ray, Mobile

AIR-SHIELDS, INC.

The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for X-ray, Portable.

Pre-market Notification Details

Device IDK781276
510k NumberK781276
Device Name:X-RAY, PORTABLE
ClassificationSystem, X-ray, Mobile
Applicant AIR-SHIELDS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-07-24
Decision Date1978-08-10

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