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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K990321
Device Name ALPHAMED GEMINI SENSOR, SNORING SENSOR
Applicant
Alphamed, Inc.
3989 Central Ave. NE
Suite 560
Minneapolis,  MN  55421
Applicant Contact PETER STASE
Correspondent
Alphamed, Inc.
3989 Central Ave. NE
Suite 560
Minneapolis,  MN  55421
Correspondent Contact PETER STASE
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/01/1999
Decision Date 06/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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