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510(k) K013376

QFLOW 500 PERFUSION MONITORING SYSTEM by Hemedex Incorporated — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2002
Date Received
October 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Hemedex Incorporated

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  • K032127 — HEMEDEX FIXATION DEVICE (December 30, 2003)
  • K032337 — HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 (October 21, 2003)

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