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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Galvanic Skin Response Measurement
510(k) Number K993824
Device Name MSAS PROFESSIONAL
Applicant
BIOMERIDIAN, INT.
12411 SOUTH 265 WEST, SUITE F
DRAPER,  UT  84020 -8671
Applicant Contact JOE GALLOWAY
Correspondent
BIOMERIDIAN, INT.
12411 SOUTH 265 WEST, SUITE F
DRAPER,  UT  84020 -8671
Correspondent Contact JOE GALLOWAY
Regulation Number882.1540
Classification Product Code
GZO  
Date Received11/12/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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