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510(k) K003122

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

K003122 is an FDA 510(k) premarket notification submitted by Florence Medical , Ltd. for the device "SMARTFLOW, MODEL SFIP 2000". The FDA issued a decision of Substantially Equivalent on May 14, 2001. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Florence Medical , Ltd. has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code DSK

  • K231586 — Endophys Blood Pressure Monitor model BPM-30 (November 3, 2023)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)
  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (December 18, 2001)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)

FDA data resources