HEMODIALYSIS SYSTEM— 510(k) K813432

Substantially Equivalent

Fhk

FDA 510(k) clearance K813432 for HEMODIALYSIS SYSTEM, Substantially Equivalent on 1982-06-23. Applicant: Fhk. Device class: 2.

Clearance details

Applicant: Fhk
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1981-12-08
Decision date: 1982-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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