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510(k) K863584

EM II STRESS TEST ELECTRODE by Electromed Intl., Ltd. — Product Code DRX

K863584 is an FDA 510(k) premarket notification submitted by Electromed Intl., Ltd. for the device "EM II STRESS TEST ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 8, 1986. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Electromed Intl., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1986
Date Received
September 15, 1986
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 Electromed Intl., Ltd.

  • K003688 — VIEW READING STATION (January 22, 2001)
  • K000474 — VIEW NT (April 19, 2000)
  • K990759 — VIEW COM (April 15, 1999)
  • K974255 — CD-R STATION AND VRS-2000 (January 27, 1998)
  • K971176 — VIEW ARCHIVING STATION (September 3, 1997)
  • K950694 — COMPACT-X (March 31, 1995)
  • K880050 — EDEC 60R (February 29, 1988)
  • K875341 — EDEC 60 R/F (February 1, 1988)
  • K875342 — EDEC 90C (January 29, 1988)
  • K871145 — EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR (March 31, 1987)

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