The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Tl-101t, Tl-120t And Tl-121t Spo2 Probes And Accessories.
| Device ID | K974292 |
| 510k Number | K974292 |
| Device Name: | NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-14 |
| Decision Date | 1998-06-08 |
| Summary: | summary |