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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K922221
Device Name SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM
Applicant
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Applicant Contact RAPHAEL HENKIN
Correspondent
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Correspondent Contact RAPHAEL HENKIN
Classification Product Code
LOS
Date Received05/12/1992
Decision Date 04/21/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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