MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP— 510(k) K864327

Name: FDA 510(k) clearance K864327
Creator: U.S. Food and Drug Administration
Published: 1987-02-06

Substantially Equivalent

Medtronic Minimed

FDA 510(k) clearance K864327 for MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP, Substantially Equivalent on 1987-02-06. Applicant: Medtronic Minimed. Device class: 1.

Clearance details

Applicant: Medtronic Minimed
Product code: Code FRW
Device class: Class 1
Regulation: 21 CFR 880.2720
Advisory panel: General Hospital
Date received: 1986-11-04
Decision date: 1987-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

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