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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K041819
Device Name GOODKNIGHT 425, MODELM-114500-00
Applicant
Mallinckrodt Developpement France
4280 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact JAMES BONDS
Correspondent
Mallinckrodt Developpement France
4280 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact JAMES BONDS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/06/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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