MODEL 2120 SPIROSCREEN— 510(k) K854403

Substantially Equivalent

Gould, Inc.

FDA 510(k) clearance K854403 for MODEL 2120 SPIROSCREEN, Substantially Equivalent on 1986-01-14. Applicant: Gould, Inc.. Device class: 2.

Clearance details

Applicant: Gould, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1985-10-31
Decision date: 1986-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, 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
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K855145 — MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR1986-02-26
K851486 — GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX1985-10-17

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