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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K070855
Device Name SLEEP QUALITY
Applicant
DYNADX CORPORATION
1676 VILLAGE GREEN STE. A
CROFTON,  MD  21114
Applicant Contact EJ Smith
Correspondent
DYNADX CORPORATION
1676 VILLAGE GREEN STE. A
CROFTON,  MD  21114
Correspondent Contact EJ Smith
Regulation Number868.2375
Classification Product Code
MNR  
Date Received03/28/2007
Decision Date 03/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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