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510(k) K850132

DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC by Consolidated Medical Equipment, Inc. — Product Code DRX

K850132 is an FDA 510(k) premarket notification submitted by Consolidated Medical Equipment, Inc. for the device "DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC". The FDA issued a decision of Substantially Equivalent on April 9, 1985. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Consolidated Medical Equipment, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1985
Date Received
January 14, 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 Consolidated Medical Equipment, Inc.

  • K854040 — I.V. DRESSING (January 9, 1986)
  • K850130 — PRN ECG ELECTRODE (April 9, 1985)
  • K850037 — CLOSED WOUND DRAIN (March 19, 1985)
  • K844942 — PLURA-GARD CHEST DRAINAGE SYSTEM (March 12, 1985)
  • K850131 — CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS (March 5, 1985)
  • K850311 — DISPOS. CONDUCTIVE ADHESIVE TENS PAD (March 5, 1985)
  • K850133 — VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. (February 28, 1985)
  • K850129 — MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN (February 28, 1985)
  • K844372 — HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE (February 21, 1985)
  • K844371 — HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE (February 20, 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