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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, peak flow, spirometry
510(k) Number K982676
Device Name AIRWATCH II ZONE
Applicant
ENACT HEALTH MANAGEMENT SYSTEMS
1975 EL CAMINO REAL WEST, #306
MOUNTAIN VIEW,  CA  94040 -2218
Applicant Contact JAMES LYON
Correspondent
ENACT HEALTH MANAGEMENT SYSTEMS
1975 EL CAMINO REAL WEST, #306
MOUNTAIN VIEW,  CA  94040 -2218
Correspondent Contact JAMES LYON
Regulation Number868.1860
Classification Product Code
BZH  
Date Received07/31/1998
Decision Date 10/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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