The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Nihon Kohden Ae-918p Neuro Unit.
| Device ID | K130238 |
| 510k Number | K130238 |
| Device Name: | NIHON KOHDEN AE-918P NEURO UNIT |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | NIHON KOHDEN CORP. 13721 VIA TRES VISTA San Diego, CA 92129 |
| Contact | Natalie Kennel |
| Correspondent | Natalie Kennel NIHON KOHDEN CORP. 13721 VIA TRES VISTA San Diego, CA 92129 |
| Product Code | OMA |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-31 |
| Decision Date | 2015-03-04 |
| Summary: | summary |