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510(k) K855145

MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR by Gould, Inc. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1986
Date Received
December 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type

Other clearances by Gould, Inc.

  • K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (July 22, 1991)
  • K861092 — MODEL SP1465 CARDIAC OUTPUT COMPUTER (August 18, 1986)
  • K860805 — PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 (May 8, 1986)
  • K854403 — MODEL 2120 SPIROSCREEN (January 14, 1986)
  • K851486 — GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX (October 17, 1985)
  • K850114 — C/PES 9201, ECG STRESS TESTING SYS (February 22, 1985)
  • K850113 — C/PES 9103, ECG STRESS TESTING SYSTEM (February 8, 1985)
  • K843555 — CARDIAC COMPUTER SP1445 (February 1, 1985)
  • K843969 — MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER (January 23, 1985)
  • K843970 — MODEL IM1074 END-TIDAL CO2 MODULE (October 24, 1984)

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  • K161408 — Compass Cast and MAP (November 22, 2016)
  • K152472 — Disposable Pressure Transducer (October 31, 2016)
  • K152980 — Flo Trac sensor, Volume View sensor (January 19, 2016)
  • K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pre (September 4, 2015)
  • K133624 — COMPASS CT, COMPASS CT PORT (April 18, 2014)
  • K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER (May 8, 2013)