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510(k) K830876

PREP-CHECK by General Devices — Product Code KRC

K830876 is an FDA 510(k) premarket notification submitted by General Devices for the device "PREP-CHECK". The FDA issued a decision of Substantially Equivalent on May 18, 1983. The device falls under product code KRC (Tester, Electrode, Surface, Electrocardiographic), a Class II device regulated under 21 CFR 870.2370. General Devices has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1983
Date Received
March 18, 1983
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 General Devices

  • K013533 — EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) (January 18, 2002)
  • K002089 — ROSETTA-LT/ROSETTA-RX (November 21, 2000)
  • K993202 — EIM-107 PREP-CHECK (December 17, 1999)
  • K940009 — GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 (April 14, 1995)
  • K935839 — GEMSCOM SERIES 5000, (November 10, 1994)
  • K921929 — GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) (September 18, 1992)
  • K914889 — GEMSCOM SERIES 3000 (March 4, 1992)
  • K912008 — TRU-VIEW MULTI-CHANNEL DISPLAY (October 9, 1991)
  • K896153 — MODIFIED DR-2C/PMC 100 (January 19, 1990)
  • K862596 — DR-2C (MODIFICATION) (September 26, 1986)

Other clearances for product code KRC

  • K023713 — SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 (January 28, 2004)
  • K872370 — BIOMA 3500 (December 7, 1987)
  • K874155 — CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (November 23, 1987)
  • K874327 — SKIN PREP ANALYZER (November 23, 1987)
  • K840358 — IMPEDANCE/8200 MONITOR-MODEL 8300 (October 30, 1984)
  • K833619 — CONDUCTANCE METER (January 27, 1984)
  • K830823 — Z VIEW METER MODEL 300 (May 18, 1983)
  • K813358 — GERARD MEDICAL ELECTRODE TESTER (December 29, 1981)
  • K780501 — ELECTRODE TESTER (May 19, 1978)
  • K771014 — TS-100 TEST SYSTEM (June 14, 1977)

FDA data resources