The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Qp-160 Ak Trend Program With The Addition Of Dsa Asymmetry Trend And Fft P.
| Device ID | K120485 |
| 510k Number | K120485 |
| Device Name: | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Steve Geerdes |
| Correspondent | Steve Geerdes NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | OMA |
| Subsequent Product Code | OLT |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-17 |
| Decision Date | 2012-03-16 |
| Summary: | summary |