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510(k) K872781

EASI LEAD SYSTEM CABLE ASSEMBLY by Totemite Medical Electronics — Product Code DRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1987
Date Received
July 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Lead Switching, Electrocardiograph
Device Class
Class II
Regulation Number
870.2350
Review Panel
CV
Submission Type

Other clearances by Totemite Medical Electronics

  • K802900 — HEART SENTINEL (March 11, 1981)

Other clearances for product code DRW

  • K033513 — EASI ECG ALGORITHM (January 15, 2004)
  • K020456 — EASI 12 LEAD ALGORITHM (July 9, 2002)
  • K930786 — EPCOR (September 26, 1994)
  • K861981 — ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR (August 25, 1986)
  • K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (November 8, 1985)
  • K851632 — PCX-100 PATIENT INPUT LEADWIRE (November 8, 1985)
  • K761210 — LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) (December 21, 1976)