RATEMINDER III INFUSION DEVICE— 510(k) K855000

Name: FDA 510(k) clearance K855000
Creator: U.S. Food and Drug Administration
Published: 1986-02-12

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K855000 for RATEMINDER III INFUSION DEVICE, Substantially Equivalent on 1986-02-12. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code LDR
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1985-12-13
Decision date: 1986-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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