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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 Apr 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 14 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 9, 1985
Date Received
Jan 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
510(k) Exempt

Other clearances by Consolidated Medical Equipment, Inc.

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

Other clearances for product code DRX

  • K171244 — Physiotrace (Aug 23, 2017)
  • K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (Jul 24, 2014)
  • K123658 — BIOMODULE 3-M1 (Apr 24, 2013)
  • K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (Jul 22, 2010)
  • K101685 — IP-SET (Jul 1, 2010)
  • K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (Jun 11, 2010)
  • K093327 — INTCO TAB ELECTRODE (May 10, 2010)
  • K100315 — 12 LEAD GLOVE (Apr 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (Dec 10, 2009)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (Oct 13, 2009)

FDA data resources

Source: FDA 510(k) database entry for K850132. Report a data issue: hello@regdatalab.com.