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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 K910950
Device Name HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED
Applicant
Vitalog Monitoring,Inc.
643 Bair Island Rd.
Suite 300
Redwood,  CA  94063
Applicant Contact LAUGHTON E MILES
Correspondent
Vitalog Monitoring,Inc.
643 Bair Island Rd.
Suite 300
Redwood,  CA  94063
Correspondent Contact LAUGHTON E MILES
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/26/1991
Decision Date 08/02/1991
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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