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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K844112
Device Name MYOPACH ULTRASONIC PACHOMETER
Applicant
Myocure, Inc.
3253 San Fernado Rd.
Los Angeles,  CA  90065
Applicant Contact ALEXA C JENSEN
Correspondent
Myocure, Inc.
3253 San Fernado Rd.
Los Angeles,  CA  90065
Correspondent Contact ALEXA C JENSEN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/23/1984
Decision Date 01/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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