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510(k) K771014

TS-100 TEST SYSTEM by Delta Medical Industries — Product Code KRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1977
Date Received
June 6, 1977
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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  • 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)
  • K830876 — PREP-CHECK (May 18, 1983)
  • K813358 — GERARD MEDICAL ELECTRODE TESTER (December 29, 1981)
  • K780501 — ELECTRODE TESTER (May 19, 1978)