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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K133051
Device Name PULMONE MINIBOX PFT TM
Applicant
Pulmone Advanced Medical Devices, Ltd.
12154 Darnestown Rd., #236
Gaithersburg,  MD  20878
Applicant Contact Rhona Shanker
Correspondent
Pulmone Advanced Medical Devices, Ltd.
12154 Darnestown Rd., #236
Gaithersburg,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Code
BZG  
Date Received09/27/2013
Decision Date 05/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01952431
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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