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FDA 510(k) Application Details - K163665
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K163665
Device Name
Ventilatory Effort Recorder
Applicant
Zephyr Sleep Technologies
610A 70 Ave SE
Calgary T2H-2J6 CA
Other 510(k) Applications for this Company
Contact
Sabina Bruehlmann
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
MNR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2016
Decision Date
05/05/2017
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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