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510(k) K872781

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

K872781 is an FDA 510(k) premarket notification submitted by Totemite Medical Electronics for the device "EASI LEAD SYSTEM CABLE ASSEMBLY". The FDA issued a decision of Substantially Equivalent on December 29, 1987. The device falls under product code DRW (Adaptor, Lead Switching, Electrocardiograph), a Class II device regulated under 21 CFR 870.2350. Totemite Medical Electronics has at least 1 other 510(k) clearance on record.

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)
  • K851632 — PCX-100 PATIENT INPUT LEADWIRE (November 8, 1985)
  • K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (November 8, 1985)
  • K761210 — LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) (December 21, 1976)

FDA data resources