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510(k) K885252

MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 by Ep Technologies, Inc. — Product Code DRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1989
Date Received
December 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Transducer Signal
Device Class
Class II
Regulation Number
870.2060
Review Panel
CV
Submission Type

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  • K924108 — TRACFINDER II (December 16, 1993)
  • K913375 — TORQUE TUBE STEEROCATH(TM) (October 25, 1991)
  • K903880 — FRANZ(TM) STEERABLE COMBINATION CATHETER (October 12, 1990)
  • K900765 — STEEROCATH(TM) (May 7, 1990)

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  • K010640 — SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER (March 20, 2001)
  • K913875 — BARD(R) BIOPOTENTIAL AMPLIFIER II (November 27, 1991)