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FDA 510(k) Application Details - K162905
Device Classification Name
Ventilator, Non-Continuous (Respirator)
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510(K) Number
K162905
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
Circadiance, LLC
1300 RODI RD
TURTLE CREEK, PA 15145 US
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Contact
JAMES GIANOUTSOS
Other 510(k) Applications for this Contact
Regulation Number
868.5905
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Classification Product Code
BZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/17/2016
Decision Date
03/15/2017
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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