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510(k) K140575

ENGSTROM CARESTATION, ENGSTROM PRO by Datex-Ohmeda, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2015
Date Received
March 6, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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  • K143530 — Aespire View (April 24, 2015)
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