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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, diagnostic
510(k) Number K141793
Device Name PULMONE MINIBOXPFT 2.0
Applicant
PULMONE ADVANCED MEDICAL DEVICES, LTD.
200 PARK AVE, UNIT 403
minneapolis,  MN  55415
Applicant Contact susan alpert
Correspondent
PULMONE ADVANCED MEDICAL DEVICES, LTD.
200 PARK AVE, UNIT 403
minneapolis,  MN  55415
Correspondent Contact susan alpert
Regulation Number868.1840
Classification Product Code
BZG  
Subsequent Product Code
BZC  
Date Received07/02/2014
Decision Date 03/06/2015
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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