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510(k) K905489

VER-MED A10017 UNIVERSAL ELECTRODE by Vermont Medical, Inc. — Product Code DRX

K905489 is an FDA 510(k) premarket notification submitted by Vermont Medical, Inc. for the device "VER-MED A10017 UNIVERSAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on March 21, 1991. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Vermont Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1991
Date Received
December 7, 1990
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 Vermont Medical, Inc.

  • K030073 — VERMED A10021 RESTING EKG TAB ELECTRODE (March 28, 2003)
  • K021537 — MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 (March 3, 2003)
  • K010638 — NEUROPLUS, MODEL A10040, A10041, A10042, A10043 (May 3, 2001)
  • K921498 — VER MED A10011 PNS DUAL ELEMENT ELECTRODE (June 9, 1993)
  • K915831 — THERMAL PROBE COVER (June 8, 1992)
  • K911687 — VER-MED A10020 RESTING EKG ELECTRODE (October 10, 1991)
  • K910139 — VER-MED A10014 RESTING EKG ELECTRODE & A10021 (August 15, 1991)
  • K781430 — PREGELLED DISPOSABLE E.K.G. ELECTRODE (October 31, 1978)

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