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510(k) K854757

5000 SERIES ECG ELECTRODES by Alternative Design Systems, Inc. — Product Code DRX

K854757 is an FDA 510(k) premarket notification submitted by Alternative Design Systems, Inc. for the device "5000 SERIES ECG ELECTRODES". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Alternative Design Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
November 27, 1985
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 Alternative Design Systems, Inc.

  • K874719 — STRATUM ESU (February 16, 1988)
  • K874697 — STRATUM D (December 15, 1987)
  • K853633 — TENS CONDUCTIVE MEDIA PAD (December 3, 1985)
  • K852515 — ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR (June 24, 1985)
  • K830778 — MONITORING KIT AMK-1 (October 14, 1983)

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