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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K873284
Device Name OXYGEN/STERILE AIR GEN SYST/SURGICAL HANDPIECES
Applicant
Litton Systems, Inc.
Hickory Grove Rd.
P.O. Box 4508
Davenport,  IA  52808
Applicant Contact THOMAS G BOYD
Correspondent
Litton Systems, Inc.
Hickory Grove Rd.
P.O. Box 4508
Davenport,  IA  52808
Correspondent Contact THOMAS G BOYD
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/17/1987
Decision Date 11/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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