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510(k) K885252

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

K885252 is an FDA 510(k) premarket notification submitted by Ep Technologies, Inc. for the device "MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001". The FDA issued a decision of Substantially Equivalent on January 13, 1989. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Ep Technologies, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Ep Technologies, Inc.

  • K043257 — REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM (February 3, 2005)
  • K013349 — ASTRONOMER PLUS SYSTEM (April 9, 2002)
  • K003452 — POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D (December 7, 2000)
  • K940167 — DIAGNOSTIC I CATHETER (August 2, 1994)
  • K940168 — DIAGNOSTIC II CATHETER (July 27, 1994)
  • K924108 — TRACFINDER II (December 16, 1993)
  • K924109 — STEEROCATH 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)

Other clearances for product code DRQ

  • K172216 — ACIST RXi Mini System (August 18, 2017)
  • K152693 — CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIG (October 21, 2015)
  • K150235 — CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARS (April 22, 2015)
  • K050006 — BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CH (May 27, 2005)
  • K050974 — DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS (April 29, 2005)
  • K033807 — INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER (March 9, 2004)
  • K013205 — MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 (July 2, 2002)
  • K020277 — SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER (February 19, 2002)
  • K010640 — SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER (March 20, 2001)
  • K913875 — BARD(R) BIOPOTENTIAL AMPLIFIER II (November 27, 1991)

FDA data resources