Nihon Kohden QP-160AK EEG Trend Program— 510(k) K163644
Substantially EquivalentNihon Kohden Corporation
FDA 510(k) clearance K163644 for Nihon Kohden QP-160AK EEG Trend Program, Substantially Equivalent on 2017-05-19. Applicant: Nihon Kohden Corporation. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden Corporation
- Product code
- Code OMA
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code OMA
view allMore clearances from Nihon Kohden Corporation
view all- K251641 — GF-310R Multigas Unit (GF-310R)
- K260747 — YP-710T Series NIBP Cuff; YP-840T Series Disposable Cuff
- K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
- K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
- K223567 — CNS-2101 Central Monitor
Data sourced from openFDA. This site is unofficial and independent of the FDA.