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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K121345
Device Name SR SUITE 1.0
Applicant
HALIFAX BIOMEDICAL, INC.
8870 RAVELLO CT
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
HALIFAX BIOMEDICAL, INC.
8870 RAVELLO CT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
LLZ   MQB  
Date Received05/04/2012
Decision Date 06/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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