Device Classification Name |
Oximeter
|
510(k) Number |
K183556 |
Device Name |
oCare Wrist Pulse Oximeter |
Applicant |
Taiwan Biophotonic Corporation |
4F-1, No. 6-1, Sec.2, Shengyi Rd. |
Zhubei,
TW
30261
|
|
Applicant Contact |
JC Chen |
Correspondent |
Taiwan Biophotonic Corporation |
4F-1, No. 6-1, Sec.2, Shengyi Rd. |
Zhubei,
TW
30261
|
|
Correspondent Contact |
JC Chen |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/20/2018 |
Decision Date | 02/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|