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510(k) K961928

BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 by Biomedix, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1996
Date Received
May 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
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)
  • K973644 — FLOSTAT VASCULAR LAB (December 23, 1997)
  • K925645 — SELEC-3 (September 27, 1993)
  • K926498 — ENDOGRIP (April 7, 1993)

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