Device Classification Name |
Oximeter
|
510(k) Number |
K150093 |
Device Name |
Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 |
Applicant |
SHENZHEN CREATIVE INDUSTRY CO., LTD. |
2/F, BLOCK 3, NANYOU TIAN'AN INDUSTRY TOWN |
SHENZHEN CITY,
CN
518054
|
|
Applicant Contact |
JIA WANG |
Correspondent |
IRC |
12226 WASHINGTON LANE |
PARKER,
AZ
85344
|
|
Correspondent Contact |
CHARLES MACK |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 01/16/2015 |
Decision Date | 06/03/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|