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510(k) K000206

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 by Axelgaard Mfg. Co., Ltd. — Product Code DRX

K000206 is an FDA 510(k) premarket notification submitted by Axelgaard Mfg. Co., Ltd. for the device "PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200". The FDA issued a decision of Substantially Equivalent on April 13, 2000. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Axelgaard Mfg. Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2000
Date Received
January 21, 2000
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 Axelgaard Mfg. Co., Ltd.

  • K132422 — PALS PLATINUM NEUROSTIMULATION ELECTRODES (February 13, 2014)
  • K130987 — VALUTRODE NEUROSTIMLATION ELECTRODES (July 17, 2013)
  • K080580 — COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MO (June 18, 2008)
  • K013532 — ULTRASTIM KIT (August 22, 2002)
  • K000947 — ULTRASTIM ELECTRODE, MODEL US4040 (June 16, 2000)
  • K983741 — EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 (December 18, 1998)
  • K970426 — VALUETRODE (May 9, 1997)
  • K874469 — TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) (January 28, 1988)
  • K872976 — TENS PALS PLUS (September 22, 1987)
  • K852267 — ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES (June 18, 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