Device Classification Name |
Oximeter
|
510(k) Number |
K081712 |
Device Name |
FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 |
Applicant |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
ZHONGSHAN NO. 2 RD., LN 999 |
SUITE 8D, NO. 19 |
SHANGHAI,
CN
200030
|
|
Applicant Contact |
Diana Hong |
Correspondent |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
ZHONGSHAN NO. 2 RD., LN 999 |
SUITE 8D, NO. 19 |
SHANGHAI,
CN
200030
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 06/17/2008 |
Decision Date | 09/12/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|