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510(k) K033513

EASI ECG ALGORITHM by Philips Medical Systems — Product Code DRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2004
Date Received
November 6, 2003
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

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Other clearances for product code DRW

  • K020456 — EASI 12 LEAD ALGORITHM (July 9, 2002)
  • K930786 — EPCOR (September 26, 1994)
  • K872781 — EASI LEAD SYSTEM CABLE ASSEMBLY (December 29, 1987)
  • 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)