INFUSART— 510(k) K844227

Substantially Equivalent

Sartorius, Inc.

FDA 510(k) clearance K844227 for INFUSART, Substantially Equivalent on 1985-01-22. Applicant: Sartorius, Inc.. Device class: 2.

Clearance details

Applicant: Sartorius, Inc.
Product code: Code FLN
Device class: Class 2
Regulation: 21 CFR 880.2420
Advisory panel: General Hospital
Date received: 1984-11-01
Decision date: 1985-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gottingen, Germany, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.