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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K771039
Device Name RESPIRATOR, PROTABLE, VOLUME CONTROLLED
Applicant
DEPT. OF THE NAVY
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DEPT. OF THE NAVY
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/09/1977
Decision Date 08/05/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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