ECOLYZER #200/COHB ANALYZER SYS— 510(k) K832655

Name: FDA 510(k) clearance K832655
Creator: U.S. Food and Drug Administration
Published: 1983-09-26

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K832655 for ECOLYZER #200/COHB ANALYZER SYS, Substantially Equivalent on 1983-09-26. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 1983-08-08
Decision date: 1983-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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