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510(k) K042616

BIOMEDIX PADNET LAB by Biomedix, Inc. — Product Code JOM

K042616 is an FDA 510(k) premarket notification submitted by Biomedix, Inc. for the device "BIOMEDIX PADNET LAB". The FDA issued a decision of Substantially Equivalent on October 12, 2004. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Biomedix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2004
Date Received
September 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
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)
  • 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)
  • 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 JOM

  • K220527 — PADnet Xpress (October 20, 2022)
  • K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (April 21, 2022)
  • K200567 — ASI Plethysmogrpah Analyzer (February 26, 2021)
  • K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system (December 11, 2020)
  • K191266 — VitalScan ANS (January 15, 2020)
  • K172655 — Automated ankle brachial pressure index measuring device (January 11, 2018)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K143152 — TM-ABI system (July 22, 2015)
  • K143094 — QuantaFlo (March 5, 2015)
  • K123921 — BODYTRONIC 200 (April 26, 2013)

FDA data resources