SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO— 510(k) K801918

Name: FDA 510(k) clearance K801918
Creator: U.S. Food and Drug Administration
Published: 1980-10-03

Substantially Equivalent

Pulmonary Testing Systems

FDA 510(k) clearance K801918 for SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO, Substantially Equivalent on 1980-10-03. Applicant: Pulmonary Testing Systems. Device class: 2.

Clearance details

Applicant: Pulmonary Testing Systems
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1980-08-11
Decision date: 1980-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K801919 — SYSTEM 88 COMPUTERIZED DIFFUSION ANALY1980-10-03
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Data sourced from openFDA. This site is unofficial and independent of the FDA.