ENGSTROM EDITH MODELS 500,1000,1500 & 1500F— 510(k) K864095

Name: FDA 510(k) clearance K864095
Creator: U.S. Food and Drug Administration
Published: 1987-02-20

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K864095 for ENGSTROM EDITH MODELS 500,1000,1500 & 1500F, Substantially Equivalent on 1987-02-20. Applicant: Gambro, Inc.. Device class: 1.

Clearance details

Applicant: Gambro, Inc.
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1986-10-21
Decision date: 1987-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

Download summary PDF View on FDA.gov ↗

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