ACCULITE SSL

Monitor, Patient Position, Light-beam

MEDICAL ALIGNMENT SYSTEMS

The following data is part of a premarket notification filed by Medical Alignment Systems with the FDA for Acculite Ssl.

Pre-market Notification Details

Device IDK923619
510k NumberK923619
Device Name:ACCULITE SSL
ClassificationMonitor, Patient Position, Light-beam
Applicant MEDICAL ALIGNMENT SYSTEMS P.O. BOX 21433 3656 MACINTOSH LANE Salt Lake City,  UT  84121
ContactGeorge N Mcdonald
CorrespondentGeorge N Mcdonald
MEDICAL ALIGNMENT SYSTEMS P.O. BOX 21433 3656 MACINTOSH LANE Salt Lake City,  UT  84121
Product CodeIWE  
CFR Regulation Number892.5780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-21
Decision Date1992-11-16

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