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510(k) K780501

ELECTRODE TESTER by Mg Medical Electronics — Product Code KRC

K780501 is an FDA 510(k) premarket notification submitted by Mg Medical Electronics for the device "ELECTRODE TESTER". The FDA issued a decision of Substantially Equivalent on May 19, 1978. The device falls under product code KRC (Tester, Electrode, Surface, Electrocardiographic), a Class II device regulated under 21 CFR 870.2370.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1978
Date Received
March 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Electrode, Surface, Electrocardiographic
Device Class
Class II
Regulation Number
870.2370
Review Panel
CV
Submission Type

Other clearances for product code KRC

  • K023713 — SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 (January 28, 2004)
  • K872370 — BIOMA 3500 (December 7, 1987)
  • K874327 — SKIN PREP ANALYZER (November 23, 1987)
  • K874155 — CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (November 23, 1987)
  • K840358 — IMPEDANCE/8200 MONITOR-MODEL 8300 (October 30, 1984)
  • K833619 — CONDUCTANCE METER (January 27, 1984)
  • K830876 — PREP-CHECK (May 18, 1983)
  • K830823 — Z VIEW METER MODEL 300 (May 18, 1983)
  • K813358 — GERARD MEDICAL ELECTRODE TESTER (December 29, 1981)
  • K771014 — TS-100 TEST SYSTEM (June 14, 1977)

FDA data resources