CO-OXIMETER SOLUTIONS— 510(k) K863825

Name: FDA 510(k) clearance K863825
Creator: U.S. Food and Drug Administration
Published: 1986-11-24

Substantially Equivalent

D.R.G. Scientific Industries

FDA 510(k) clearance K863825 for CO-OXIMETER SOLUTIONS, Substantially Equivalent on 1986-11-24. Applicant: D.R.G. Scientific Industries. Device class: 1.

Clearance details

Applicant: D.R.G. Scientific Industries
Product code: Code JKS
Device class: Class 1
Regulation: 21 CFR 862.3220
Advisory panel: Clinical Toxicology
Date received: 1986-09-30
Decision date: 1986-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Boston, MA, US

Download summary PDF View on FDA.gov ↗

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