Device Classification Name |
Oximeter
|
510(k) Number |
K083079 |
Device Name |
QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 |
Applicant |
QUANTA COMPUTER INC. |
2904 N. BOLDT DR. |
FLAGSTAFF,
AZ
86001
|
|
Applicant Contact |
JENNIFER REICH |
Correspondent |
QUANTA COMPUTER INC. |
2904 N. BOLDT DR. |
FLAGSTAFF,
AZ
86001
|
|
Correspondent Contact |
JENNIFER REICH |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 10/16/2008 |
Decision Date | 03/05/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|