Device Classification Name |
accessories, pump, infusion
|
510(k) Number |
K142374 |
Device Name |
ivWatch Model 400 |
Applicant |
ivWatch, LLC |
469 McLaws Circle |
Williamsburg,
VA
23185
|
|
Applicant Contact |
Javier Garriz |
Correspondent |
ivWatch, LLC |
469 McLaws Circle |
Williamsburg,
VA
23185
|
|
Correspondent Contact |
Javier Garriz |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/26/2014 |
Decision Date | 02/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|