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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K242447
Device Name Falcon HST
Applicant
Compumedics Limited
30-40 Flockhart St
Abbotsford,  AU 3067
Applicant Contact John Joseph
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Codes
MNR   OMC  
Date Received08/16/2024
Decision Date 02/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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