510(k) K072843

YG-125T AND YG-135T NASAL ADAPTER by Nihon Kohden America, Inc. — Product Code CCK

K072843 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "YG-125T AND YG-135T NASAL ADAPTER". The FDA issued a decision of Substantially Equivalent on November 29, 2007. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2007
Date Received
October 4, 2007
Clearance Type
Special
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