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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K852677
Device Name MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM
Applicant
Alpha Technologies, Inc.
23142-A Alcalde
Laguna Hills,  CA  92653
Applicant Contact DENNIS A NEFF
Correspondent
Alpha Technologies, Inc.
23142-A Alcalde
Laguna Hills,  CA  92653
Correspondent Contact DENNIS A NEFF
Regulation Number868.1840
Classification Product Code
BZG  
Date Received06/24/1985
Decision Date 07/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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