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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K942593
Device Name OXYCHEK OXYGEN ANALYZER
Applicant
Nidek Medical Products, Inc.
3949 Valley E. Industrial Dr.
Birmingham,  AL  35217
Applicant Contact GREGG GASKINS
Correspondent
Nidek Medical Products, Inc.
3949 Valley E. Industrial Dr.
Birmingham,  AL  35217
Correspondent Contact GREGG GASKINS
Regulation Number868.1720
Classification Product Code
CCL  
Date Received06/01/1994
Decision Date 05/03/1995
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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