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510(k) K973857

FLOSTAT VASCULAR REPORT GENERATOR (VRG) by Biomedix, Inc. — Product Code JAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1997
Date Received
October 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

Other clearances by Biomedix, Inc.

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  • K073146 — PADNET+ (November 21, 2007)
  • K050182 — Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM (August 9, 2005)
  • K042616 — BIOMEDIX PADNET LAB (October 12, 2004)
  • K033627 — Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM (May 21, 2004)
  • K973644 — FLOSTAT VASCULAR LAB (December 23, 1997)
  • K961928 — BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 (September 16, 1996)
  • K925645 — SELEC-3 (September 27, 1993)
  • K926498 — ENDOGRIP (April 7, 1993)

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  • K110628 — SIMPLEABI (May 12, 2011)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090009 — THD SLIDE ONE (January 28, 2009)
  • K081429 — THD SLIDE (July 30, 2008)
  • K070815 — THD (June 20, 2007)
  • K063600 — VISTA AVS (December 19, 2006)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)