SR SUITE 1.0

System, X-ray, Stationary

HALIFAX BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Halifax Biomedical, Inc. with the FDA for Sr Suite 1.0.

Pre-market Notification Details

Device IDK121345
510k NumberK121345
Device Name:SR SUITE 1.0
ClassificationSystem, X-ray, Stationary
Applicant HALIFAX BIOMEDICAL, INC. 8870 RAVELLO CT Naples,  FL  34114
ContactDaniel Kamm
CorrespondentDaniel Kamm
HALIFAX BIOMEDICAL, INC. 8870 RAVELLO CT Naples,  FL  34114
Product CodeKPR  
Subsequent Product CodeLLZ
Subsequent Product CodeMQB
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-04
Decision Date2012-06-01
Summary:summary

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