NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P— 510(k) K120485
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K120485 for NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P, Substantially Equivalent on 2012-03-16. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- 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
- Special
- Location
- Foothill, CA, US
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