TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (K243956)
Description
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) by Nihon Kohden Corporation, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243956
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (K243956) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161860 | TG-970P CO2 Sensor Kit | Nihon Kohden Corporation | 2017 |
| K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | Nihon Kohden America, Inc. | 2009 |
| K033456 | EVOLVE RADIAL PLATE | Wrightmedicaltechnologyinc | 2004 |
Trace the full predicate network for K243956
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.