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510(k) K791006

SMART BILECTRODES by Electronics For Medicine, Inc. — Product Code DRX

K791006 is an FDA 510(k) premarket notification submitted by Electronics For Medicine, Inc. for the device "SMART BILECTRODES". The FDA issued a decision of Substantially Equivalent on June 11, 1979. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Electronics For Medicine, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1979
Date Received
May 31, 1979
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 Electronics For Medicine, Inc.

  • K830791 — UNIVERSAL MEDDARS SYSTEM (June 22, 1983)
  • K830795 — CABINET FOR MULTIPLE FUNCTION BLOCKS (May 18, 1983)
  • K792528 — RESPIRATION/APNEA AMPLIFIER MODEL 3105 (February 21, 1980)
  • K790198 — MONITOR PLUG-IN MODEL M1106 ECG (March 6, 1979)
  • K790203 — INTERVAL TIMER MODEL V4295 (March 2, 1979)
  • K790185 — MODEL V 4207 INTEGRATING PLUG-IN (February 16, 1979)
  • K780107 — ANALYZER-PLUG-IN, CO2 MODEL M 3104 (January 30, 1978)
  • K770366 — ISOLATED ELECTROCARDIOGRAPH MODEL 1207 (March 1, 1977)

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