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510(k) K833619

CONDUCTANCE METER by Circadian, Inc. — Product Code KRC

K833619 is an FDA 510(k) premarket notification submitted by Circadian, Inc. for the device "CONDUCTANCE METER". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code KRC (Tester, Electrode, Surface, Electrocardiographic), a Class II device regulated under 21 CFR 870.2370. Circadian, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1984
Date Received
October 14, 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 Circadian, Inc.

  • K921878 — SCANMATE III (September 11, 1992)
  • K894956 — CIRCAMED HOLTER VERSION 4 (February 5, 1990)
  • K874641 — CIRCADIAN STRESS TEST II (April 1, 1988)
  • K874155 — CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (November 23, 1987)
  • K871251 — CIRCAMED FULL DISCLOSURE SYSTEM (May 22, 1987)
  • K860973 — CIRCADIAN STRESS TEST SYSTEM (August 25, 1986)
  • K851517 — CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO (October 2, 1985)
  • K851643 — REMOTE CONTROL MODULE (September 9, 1985)
  • K840741 — PULMONARY FUNCTION TESTING STS (March 5, 1984)
  • K830830 — CIRCA MED TWO-CHANNEL (June 18, 1983)

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)
  • K830823 — Z VIEW METER MODEL 300 (May 18, 1983)
  • K830876 — PREP-CHECK (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