510(k) K072843
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