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510(k) K042105

CLIPPER DIAGNOSTIC ELECTRODE CATHETER by Bard Electrophysiology — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2004
Date Received
August 4, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Bard Electrophysiology

  • K913875 — BARD(R) BIOPOTENTIAL AMPLIFIER II (November 27, 1991)
  • K893611 — BARD PLAQUE ELECTRODE ARRAY (July 14, 1989)

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