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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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