The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Long Term Recorder Rag 1200.
| Device ID | K854866 |
| 510k Number | K854866 |
| Device Name: | LONG TERM RECORDER RAG 1200 |
| Classification | Recorder, Paper Chart |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Dennis Javens |
| Correspondent | Dennis Javens 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 | 1985-11-08 |
| Decision Date | 1986-04-09 |