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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 K031202
Device Name MEDIPALM-20
Applicant
BRAEBON MEDICAL CORP.
120 WALGREEN DR (RR#3)
SUITE #1
CARP, ONTARIO,  CA K0A 1L0
Applicant Contact RICHARD A BONATO
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number882.1400
Classification Product Code
OLV  
Date Received04/16/2003
Decision Date 05/01/2003
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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