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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 K000700
Device Name SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
Applicant
Sensidyne, Inc.
16333 Bay Vista Dr.
Clearwater,  FL  33760
Applicant Contact HOWARD MILLS
Correspondent
Sensidyne, Inc.
16333 Bay Vista Dr.
Clearwater,  FL  33760
Correspondent Contact HOWARD MILLS
Regulation Number868.1720
Classification Product Code
CCL  
Date Received03/01/2000
Decision Date 08/31/2000
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
Recalls CDRH Recalls
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