The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ws 800r Thermal Array Recorder.
| Device ID | K881831 |
| 510k Number | K881831 |
| Device Name: | WS 800R THERMAL ARRAY RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Mike Dashefsky |
| Correspondent | Mike Dashefsky NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-29 |
| Decision Date | 1988-07-14 |