37-702 AND 37-703 PC RAINBOW

Collimator, Orthovoltage, Therapeutic X-ray

VICTOREEN, INC.

The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for 37-702 And 37-703 Pc Rainbow.

Pre-market Notification Details

Device IDK900932
510k NumberK900932
Device Name:37-702 AND 37-703 PC RAINBOW
ClassificationCollimator, Orthovoltage, Therapeutic X-ray
Applicant VICTOREEN, INC. 100 VOICE RD. Carle Place,  NY  11514
ContactGlasser
CorrespondentGlasser
VICTOREEN, INC. 100 VOICE RD. Carle Place,  NY  11514
Product CodeIYI  
CFR Regulation Number892.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-28
Decision Date1990-12-05

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