The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Tg-970p Sensor Kit W/ New Airway Adapter (yg-213t).
| Device ID | K122214 |
| 510k Number | K122214 |
| Device Name: | TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch, CA 92610 |
| Contact | Steve Geerdes |
| Correspondent | Steve Geerdes NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch, CA 92610 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2013-05-21 |
| Summary: | summary |