Device Classification Name |
Sleeve, Limb, Compressible
More FDA Info for this Device |
510(K) Number |
K203746 |
Device Name |
Sleeve, Limb, Compressible |
Applicant |
Shenzhen Pango Electronic CO., LTD
No.25, 1st Industry Zone, Fenghuang Road, Xikeng Village,
Henggang Town, Longgang Distict
Shenzhen 518115 CN
Other 510(k) Applications for this Company
|
Contact |
Guojun Zeng
Other 510(k) Applications for this Contact |
Regulation Number |
870.5800
More FDA Info for this Regulation Number |
Classification Product Code |
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/22/2020 |
Decision Date |
11/10/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|