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510(k) K851486

GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX by Gould, Inc. — Product Code DRS

K851486 is an FDA 510(k) premarket notification submitted by Gould, Inc. for the device "GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX". The FDA issued a decision of Substantially Equivalent on October 17, 1985. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Gould, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1985
Date Received
April 15, 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)
  • K855145 — MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR (February 26, 1986)
  • K854403 — MODEL 2120 SPIROSCREEN (January 14, 1986)
  • 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)

Other clearances for product code DRS

  • K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (March 21, 2025)
  • K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (March 17, 2023)
  • K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (November 9, 2017)
  • K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (May 24, 2017)
  • 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)

FDA data resources