Device Classification Name |
oximeter
|
510(k) Number |
K021090 |
Device Name |
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER |
Applicant |
NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Applicant Contact |
GINA TO |
Correspondent |
NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Correspondent Contact |
GINA TO |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 04/04/2002 |
Decision Date | 05/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|