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510(k) K861092

MODEL SP1465 CARDIAC OUTPUT COMPUTER by Gould, Inc. — Product Code DXG

K861092 is an FDA 510(k) premarket notification submitted by Gould, Inc. for the device "MODEL SP1465 CARDIAC OUTPUT COMPUTER". The FDA issued a decision of Substantially Equivalent on August 18, 1986. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Gould, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1986
Date Received
March 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Gould, Inc.

  • K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (July 22, 1991)
  • 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)
  • 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)

Other clearances for product code DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)

FDA data resources