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510(k) K872370

BIOMA 3500 by E.B.S., Inc. — Product Code KRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1987
Date Received
June 19, 1987
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 E.B.S., Inc.

  • K880036 — BIOMA 5000 (March 7, 1988)
  • K862808 — BIOMA 2000 (February 19, 1987)

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  • 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)
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  • K771014 — TS-100 TEST SYSTEM (June 14, 1977)