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510(k) K131339

CAPNOMASK by Mediplus , Ltd. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2013
Date Received
May 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Mediplus , Ltd.

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  • K013704 — MEDIPLUS SINGLE USE GI MANOMETRY CATHETER (August 5, 2002)

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