Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K181217 |
Device Name |
VesoFlow Lite DVT Compression Device |
Applicant |
Caremed Supply, Inc. |
7F., No. 2, Lane 235, Baoqiao Rd., Xindien Dist. |
New Taipei City,
TW
23145
|
|
Applicant Contact |
Tsung-Hsuan Liu |
Correspondent |
Caremed Supply, Inc. |
7F., No. 2, Lane 235, Baoqiao Rd., Xindien Dist. |
New Taipei City,
TW
23145
|
|
Correspondent Contact |
Tsung-Hsuan Liu |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 05/07/2018 |
Decision Date | 08/05/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|