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510(k) K770988

FOAM ECG ELECTRODE, 2060 AND 2061 by Cardio-Dynamics Laboratories, Inc. — Product Code DRX

K770988 is an FDA 510(k) premarket notification submitted by Cardio-Dynamics Laboratories, Inc. for the device "FOAM ECG ELECTRODE, 2060 AND 2061". The FDA issued a decision of Substantially Equivalent on June 14, 1977. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Cardio-Dynamics Laboratories, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1977
Date Received
May 31, 1977
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 Cardio-Dynamics Laboratories, Inc.

  • K781911 — ECG ANALYZER, HIGH SPEED (November 30, 1978)
  • K781514 — ECG ELECTRODE, 2021, 2022, 2032, 2033 (October 17, 1978)
  • K781152 — ELECTROCARDIOGRAPHIC ECG RECORDER (August 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