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 |