The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Vitaport 3.
| Device ID | K000338 |
| 510k Number | K000338 |
| Device Name: | VITAPORT 3 |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-03 |
| Decision Date | 2000-04-26 |