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510(k) K813358

GERARD MEDICAL ELECTRODE TESTER by Gerard Medical Enterprises, Inc. — Product Code KRC

K813358 is an FDA 510(k) premarket notification submitted by Gerard Medical Enterprises, Inc. for the device "GERARD MEDICAL ELECTRODE TESTER". The FDA issued a decision of Substantially Equivalent on December 29, 1981. The device falls under product code KRC (Tester, Electrode, Surface, Electrocardiographic), a Class II device regulated under 21 CFR 870.2370. Gerard Medical Enterprises, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
November 30, 1981
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 by Gerard Medical Enterprises, Inc.

  • K954258 — TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) (May 24, 1996)
  • K945250 — TRIMPORT (March 7, 1995)
  • K942623 — TRIMPORT (August 23, 1994)
  • K922147 — DUAL PLASTIC VASCULAR ACCESS SYSTEM (December 4, 1992)
  • K913114 — TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT (January 2, 1992)
  • K912111 — MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE (October 8, 1991)
  • K903364 — GERARD MEDICAL, INC. TRIM-PORT (October 31, 1990)

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)
  • K780501 — ELECTRODE TESTER (May 19, 1978)
  • K771014 — TS-100 TEST SYSTEM (June 14, 1977)

FDA data resources