ODYSSEY INSTRUMENTATION SYSTEM— 510(k) K981294

Name: FDA 510(k) clearance K981294
Creator: U.S. Food and Drug Administration
Published: 1998-07-08

Substantially Equivalent

Automata Instrumentation, Inc.

FDA 510(k) clearance K981294 for ODYSSEY INSTRUMENTATION SYSTEM, Substantially Equivalent on 1998-07-08. Applicant: Automata Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Automata Instrumentation, Inc.
Product code: Code FIZ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1998-04-09
Decision date: 1998-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

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