| Device Classification Name |
monitor, breathing frequency
|
| 510(k) Number | K891486 |
| Device Name | AR-800PA RESPIRATION MODULE |
| Applicant |
| NIHON KOHDEN AMERICA, INC. |
17112 armstrong ave. |
irvine,
CA
92714 |
|
| Contact | mike dashefsky |
| Regulation Number | 868.2375 |
| Classification Product Code |
|
| Date Received | 03/17/1989 |
| Decision Date | 10/24/1989 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Anesthesiology
|
| Review Advisory Committee |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
|
|
|