Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K200856 |
Device Name |
SmartLinx Vitals Plus Patient Monitoring System |
Applicant |
Capsule Technologie SAS |
300 Brickstone Square, Suite 203 |
Andover,
MA
01810
|
|
Applicant Contact |
Peter Kelley |
Correspondent |
Capsule Technologie SAS |
300 Brickstone Square, Suite 203 |
Andover,
MA
01810
|
|
Correspondent Contact |
Peter Kelley |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/01/2020 |
Decision Date | 07/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|