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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K874395
Device Name RESPIRGARD II NEBULIZER SYSTEM
Applicant
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Applicant Contact JOHN ADAMS
Correspondent
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Correspondent Contact JOHN ADAMS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/28/1987
Decision Date 12/21/1987
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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