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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
510(k) Number K885079
Device Name HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275
Applicant
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Applicant Contact RONALD A WIDMAN
Correspondent
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Correspondent Contact RONALD A WIDMAN
Regulation Number868.2500
Classification Product Code
LPP  
Date Received12/08/1988
Decision Date 02/17/1989
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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