Submission Details
| 510(k) Number | K072843 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 04, 2007 |
| Decision Date | November 29, 2007 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
YG-125T AND YG-135T NASAL ADAPTER
Nov 2007
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K072843 is an FDA 510(k) clearance for the YG-125T AND YG-135T NASAL ADAPTER, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on November 29, 2007, 56 days after receiving the submission on October 4, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.
Device Classification
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1400 |
Manufacturer
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