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510(k) K031153

MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 by Arrow Intl., Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2003
Date Received
April 11, 2003
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

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  • K060309 — AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES (April 6, 2006)
  • K042126 — PICC (August 27, 2004)
  • K041153 — SHARPSAWAY II LOCKING DISPOSABLE CUP (July 12, 2004)
  • K040801 — INTRA-AORTIC BALLOON (IAB) (May 6, 2004)
  • K040802 — HEMOSONIC 200HEMODYNAMIC MONITOR (April 28, 2004)

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