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510(k) K020456

EASI 12 LEAD ALGORITHM by Philips Medical Systems — Product Code DRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2002
Date Received
February 11, 2002
Clearance Type
Special
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

  • K033513 — EASI ECG ALGORITHM (January 15, 2004)
  • 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)