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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K091853
Device Name WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
Applicant
NSPIRE HEALTH, INC.
1830 LEFTHAND CIRCLE
LONGMONT,  CO  80501
Applicant Contact KIMBERLY STARK
Correspondent
NSPIRE HEALTH, INC.
1830 LEFTHAND CIRCLE
LONGMONT,  CO  80501
Correspondent Contact KIMBERLY STARK
Regulation Number868.1850
Classification Product Code
BZK  
Date Received06/23/2009
Decision Date 09/21/2009
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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