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510(k) K003122

SMARTFLOW, MODEL SFIP 2000 by Florence Medical , Ltd. — Product Code DSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2001
Date Received
October 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type

Other clearances by Florence Medical , Ltd.

  • K020127 — SMARTFLOW PULSE TRANSMISSION COEFFICIENT (February 14, 2002)
  • K012947 — SMARTFLOW (October 2, 2001)

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