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510(k) K042566

VASC-ALERT by Vasc-Alert, Inc. — Product Code MQS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2004
Date Received
September 21, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemodialysis, Access Recirculation Monitoring
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Vasc-Alert, Inc.

  • K030456 — VASC-ALERT (July 11, 2003)

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  • K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010 (August 12, 2002)
  • K001763 — CRIT-LINE MONITOR III (CLM III) (December 20, 2000)
  • K993587 — HP M2376A DEVICE LINK SYSTEM (January 20, 2000)
  • K992227 — CRIT-LINE MONITOR III (CLM III) (July 30, 1999)
  • K984194 — HP M2376A DEVICE LINK SYSTEM (April 30, 1999)
  • K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (October 9, 1998)