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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 K062388
Device Name ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
Applicant
DOCUSYS
820 SOUTH UNIVERSITY BLVD
SUITE 3-H
MOBILE,  AL  36609
Applicant Contact GORDON J PETERS
Correspondent
DOCUSYS
820 SOUTH UNIVERSITY BLVD
SUITE 3-H
MOBILE,  AL  36609
Correspondent Contact GORDON J PETERS
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/15/2006
Decision Date 02/22/2007
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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