Home / 510(k) Clearances / K973644

510(k) K973644

FLOSTAT VASCULAR LAB by Biomedix, Inc. — Product Code JAF

K973644 is an FDA 510(k) premarket notification submitted by Biomedix, Inc. for the device "FLOSTAT VASCULAR LAB". The FDA issued a decision of Substantially Equivalent on December 23, 1997. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Biomedix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1997
Date Received
September 24, 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.

  • K142097 — SELEC-3 I.V.ADMINISTRATION SET (August 29, 2014)
  • K122281 — PADNET 2.0 (August 29, 2012)
  • 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)
  • K973857 — FLOSTAT VASCULAR REPORT GENERATOR (VRG) (December 29, 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)

Other clearances for product code JAF

  • K242487 — Laminar P1 (LDH-HW-001) (December 13, 2024)
  • K141657 — THD REVOLUTION (February 24, 2015)
  • 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)

FDA data resources