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FDA 510(k) Application Details - K161534
Device Classification Name
Calculator, Predicted Values, Pulmonary Function
More FDA Info for this Device
510(K) Number
K161534
Device Name
Calculator, Predicted Values, Pulmonary Function
Applicant
NDD MEDIZINTECHNIK AG
TECHNOPARKSTRASSE 1
ZURICH 8005 CH
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Contact
N/A N/A
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Regulation Number
868.1890
More FDA Info for this Regulation Number
Classification Product Code
BTY
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More FDA Info for this Product Code
Date Received
06/03/2016
Decision Date
02/22/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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