RAINCOAT— 510(k) K863910

Name: FDA 510(k) clearance K863910
Creator: U.S. Food and Drug Administration
Published: 1986-10-20

Substantially Equivalent

Artec Environmental Monitoring Division

FDA 510(k) clearance K863910 for RAINCOAT, Substantially Equivalent on 1986-10-20. Applicant: Artec Environmental Monitoring Division. Device class: 1.

Clearance details

Applicant: Artec Environmental Monitoring Division
Product code: Code BZO
Device class: Class 1
Regulation: 21 CFR 868.5975
Advisory panel: Anesthesiology
Date received: 1986-10-08
Decision date: 1986-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noblesville, IN, US

Download summary PDF View on FDA.gov ↗

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