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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K990659
Device Name NASAL AIRE
Applicant
BREATHING TECHNOLOGIES CORP.
11000 WESTON PKWY.
CARY,  NC  27709
Applicant Contact TERRY C MCMAHAON
Correspondent
BREATHING TECHNOLOGIES CORP.
11000 WESTON PKWY.
CARY,  NC  27709
Correspondent Contact TERRY C MCMAHAON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/01/1999
Decision Date 11/26/1999
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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