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510(k) K840358

IMPEDANCE/8200 MONITOR-MODEL 8300 by Aequitron Medical, Inc. — Product Code KRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
January 26, 1984
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

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  • K905244 — MODEL LP6 VENTILATOR, MODIFICATION (November 30, 1990)
  • K901656 — MODEL 9200 RESPIRATION/HEART RATE MONITOR (July 13, 1990)

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  • K874327 — SKIN PREP ANALYZER (November 23, 1987)
  • 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)
  • K780501 — ELECTRODE TESTER (May 19, 1978)
  • K771014 — TS-100 TEST SYSTEM (June 14, 1977)