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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
Original Applicant
Regulation Number862.1660
Classification Product Code
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