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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 K883591
Device Name MARK-5 CONCENTRATOR
Applicant
Nidek Medical Products, Inc.
2706 S. 19th St.
Birmingham,  AL  35209
Applicant Contact DON HUNTER
Correspondent
Nidek Medical Products, Inc.
2706 S. 19th St.
Birmingham,  AL  35209
Correspondent Contact DON HUNTER
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/23/1988
Decision Date 11/02/1988
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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