The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ar-800pa Respiration Module.
| Device ID | K891486 |
| 510k Number | K891486 |
| Device Name: | AR-800PA RESPIRATION MODULE |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-10-24 |