FRESENIUS HEMODIALYSIS MACHINE A1008 BSM— 510(k) K855001

Name: FDA 510(k) clearance K855001
Creator: U.S. Food and Drug Administration
Published: 1986-01-21

Substantially Equivalent

Seratronics, Inc.

FDA 510(k) clearance K855001 for FRESENIUS HEMODIALYSIS MACHINE A1008 BSM, Substantially Equivalent on 1986-01-21. Applicant: Seratronics, Inc.. Device class: 2.

Clearance details

Applicant: Seratronics, Inc.
Product code: Code FLC
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-12-13
Decision date: 1986-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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