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
|
|
Applicant Contact |
MIKE DASHEFSKY |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
17112 ARMSTRONG AVE. |
IRVINE,
CA
92714
|
|
Correspondent Contact |
MIKE DASHEFSKY |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 03/17/1989 |
Decision Date | 10/24/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|