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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 K052335
Device Name ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
Applicant
ACCUTRON, INC.
13605 WEST 7TH AVENUE
GOLDEN,  CO  80401 -4604
Applicant Contact ROBERT N CLARK
Correspondent
ACCUTRON, INC.
13605 WEST 7TH AVENUE
GOLDEN,  CO  80401 -4604
Correspondent Contact ROBERT N CLARK
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/26/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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