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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Air Embolism, Ultrasonic
510(k) Number K780703
Device Name CUFF PACER
Applicant
OMP LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OMP LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2025
Classification Product Code
CBA  
Date Received04/25/1978
Decision Date 07/17/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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