NEO-STAT DIALYSATE METER— 510(k) K920810

Name: FDA 510(k) clearance K920810
Creator: U.S. Food and Drug Administration
Published: 1993-01-15

Substantially Equivalent

Automata Medical Instrumentation, Inc.

FDA 510(k) clearance K920810 for NEO-STAT DIALYSATE METER, Substantially Equivalent on 1993-01-15. Applicant: Automata Medical Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Automata Medical Instrumentation, Inc.
Product code: Code FIZ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-21
Decision date: 1993-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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