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510(k) K092291

SKINTACT AND VARIOUS OTHER TRADENAMES by Leonhard Lang GmbH — Product Code DRX

K092291 is an FDA 510(k) premarket notification submitted by Leonhard Lang GmbH for the device "SKINTACT AND VARIOUS OTHER TRADENAMES". The FDA issued a decision of Substantially Equivalent on August 21, 2009. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Leonhard Lang GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2009
Date Received
July 29, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

Other clearances by Leonhard Lang GmbH

  • K142803 — Skintact, various other tradenames (December 2, 2014)
  • K140500 — SKINTACT (July 29, 2014)
  • K140340 — SKINTACT (May 21, 2014)
  • K103186 — SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES (February 8, 2011)
  • K081371 — SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL (September 24, 2008)
  • K080106 — SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE (February 1, 2008)
  • K073104 — SKINTACT AND VARIOUS OTHER TRADENAMES (November 16, 2007)
  • K072233 — SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMP (October 5, 2007)
  • K063161 — SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL (November 21, 2006)
  • K041883 — SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 (September 7, 2004)

Other clearances for product code DRX

  • K171244 — Physiotrace (August 23, 2017)
  • K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (July 24, 2014)
  • K123658 — BIOMODULE 3-M1 (April 24, 2013)
  • K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (July 22, 2010)
  • K101685 — IP-SET (July 1, 2010)
  • K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (June 11, 2010)
  • K093327 — INTCO TAB ELECTRODE (May 10, 2010)
  • K100315 — 12 LEAD GLOVE (April 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)

FDA data resources