DIALYSIS CONTROL UNIT-CENTRY 2000— 510(k) K802250

Name: FDA 510(k) clearance K802250
Creator: U.S. Food and Drug Administration
Published: 1980-12-10

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K802250 for DIALYSIS CONTROL UNIT-CENTRY 2000, Substantially Equivalent on 1980-12-10. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1980-09-16
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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