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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K970163
Device Name ALPHA MX (20)/ULTRA PC (30)
Applicant
Technical Medical Products, Inc.
2020 W. Melinda Ln.
Phoenix,  AZ  85027
Applicant Contact JIM R MOORE
Correspondent
Technical Medical Products, Inc.
2020 W. Melinda Ln.
Phoenix,  AZ  85027
Correspondent Contact JIM R MOORE
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received01/16/1997
Decision Date 12/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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