VASC-ALERT
System, Hemodialysis, Access Recirculation Monitoring
VASC-ALERT, INC.
The following data is part of a premarket notification filed by Vasc-alert, Inc. with the FDA for Vasc-alert.
Pre-market Notification Details
| Device ID | K042566 |
| 510k Number | K042566 |
| Device Name: | VASC-ALERT |
| Classification | System, Hemodialysis, Access Recirculation Monitoring |
| Applicant | VASC-ALERT, INC. 1807 WEST SUNNYSIDE AVE. SUITE 301 Chicago, IL 60640 |
| Contact | John B Kennedy |
| Correspondent | John B Kennedy VASC-ALERT, INC. 1807 WEST SUNNYSIDE AVE. SUITE 301 Chicago, IL 60640 |
| Product Code | MQS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-21 |
| Decision Date | 2004-11-08 |
| Summary: | summary |
Trademark Results [VASC-ALERT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VASC-ALERT 85033903 3897036 Live/Registered |
Vasc-Alert LLC 2010-05-10 |
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