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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
510(k) Number K781386
Device Name EBS 775 TONOMETER
Applicant
Equilibrated Bio Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Equilibrated Bio Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1660
Classification Product Code
LCH  
Date Received08/11/1978
Decision Date 09/14/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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