The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ambulatory Eeg/sleep Recorder And Accessories, Model # Ssr3201.
| Device ID | K983072 |
| 510k Number | K983072 |
| Device Name: | AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Gary Reasoner |
| Correspondent | Gary Reasoner 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 | 1998-09-02 |
| Decision Date | 1998-12-01 |
| Summary: | summary |