CARDIAC COMPUTER SP1445— 510(k) K843555

Substantially Equivalent

Gould, Inc.

FDA 510(k) clearance K843555 for CARDIAC COMPUTER SP1445, Substantially Equivalent on 1985-02-01. Applicant: Gould, Inc.. Device class: 2.

Clearance details

Applicant: Gould, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1984-09-10
Decision date: 1985-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxnard, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gould, Inc.

K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED1991-07-22
K861092 — MODEL SP1465 CARDIAC OUTPUT COMPUTER1986-08-18
K860805 — PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP53371986-05-08
K855145 — MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR1986-02-26
K854403 — MODEL 2120 SPIROSCREEN1986-01-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.