Device Classification Name |
oximeter
|
510(k) Number |
K992455 |
Device Name |
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES |
Applicant |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Applicant Contact |
BONNIE BISHOP |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Correspondent Contact |
BONNIE BISHOP |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 07/23/1999 |
Decision Date | 01/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|