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510(k) K050443

ACCU-LEAD by Kentec Medical, Inc. — Product Code DRX

K050443 is an FDA 510(k) premarket notification submitted by Kentec Medical, Inc. for the device "ACCU-LEAD". The FDA issued a decision of Substantially Equivalent on September 2, 2005. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Kentec Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2005
Date Received
February 22, 2005
Clearance Type
Traditional
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 Kentec Medical, Inc.

  • K120272 — AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET (February 17, 2012)
  • K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (April 22, 2010)
  • K970686 — ACCUTEMP-PROBE (August 25, 1997)
  • K960080 — ACCUTEMP PROBE (May 1, 1996)
  • K853475 — GRAM-MA NEONATAL SC (September 5, 1985)

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