| Device Classification Name |
oximeter
|
| 510(k) Number |
K080238 |
| Device Name |
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER |
| Applicant |
| MASIMO CORPORATION |
| 40 PARKER |
|
irvine,
CA
92618
|
|
| Applicant Contact |
marquerite thomlinson |
| Correspondent |
| MASIMO CORPORATION |
| 40 PARKER |
|
irvine,
CA
92618
|
|
| Correspondent Contact |
marquerite thomlinson |
| Regulation Number | 870.2700
|
| Classification Product Code |
|
| Subsequent Product Codes |
|
| Date Received | 01/31/2008 |
| Decision Date | 05/12/2008 |
| Decision |
substantially equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Anesthesiology
|
| summary |
summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
| Recalls |
CDRH Recalls
|
|
|