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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, drug dose
510(k) Number K142123
Device Name REACH ACCESS TELEMEDICINE DOSE CALCULATOR
Applicant
REACH HEALTH, INC.
10745 WESTSIDE WAY
Alpharetta,  GA  30009
Applicant Contact BETH DESTASIO
Correspondent
REACH HEALTH, INC.
10745 WESTSIDE WAY
Alpharetta,  GA  30009
Correspondent Contact BETH DESTASIO
Regulation Number868.1890
Classification Product Code
NDC  
Subsequent Product Codes
LLZ   OUG  
Date Received08/04/2014
Decision Date 09/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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