PSG INPUT BOX, MODEL JE-912AK— 510(k) K022121
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K022121 for PSG INPUT BOX, MODEL JE-912AK, Substantially Equivalent on 2002-07-29. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code OLV
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Foothill, CA, US
Recent devices under product code OLV
view allMore clearances from Nihon Kohden America, Inc.
view all- K113117 — NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
- K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
- K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM
- K083456 — NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
- K083271 — BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
Data sourced from openFDA. This site is unofficial and independent of the FDA.