AZ 92

Monitor, Patient Position, Light-beam

A2J, INC.

The following data is part of a premarket notification filed by A2j, Inc. with the FDA for Az 92.

Pre-market Notification Details

Device IDK931974
510k NumberK931974
Device Name:AZ 92
ClassificationMonitor, Patient Position, Light-beam
Applicant A2J, INC. 225 INDUSTRIAL CT. Fredericksburg,  VA  22408
ContactJim L.
CorrespondentJim L.
A2J, INC. 225 INDUSTRIAL CT. Fredericksburg,  VA  22408
Product CodeIWE  
CFR Regulation Number892.5780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-22
Decision Date1993-10-08

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