POET IQ WITH FIVE AGENT CAPABILITY— 510(k) K942737

Name: FDA 510(k) clearance K942737
Creator: U.S. Food and Drug Administration
Published: 1995-02-09

Substantially Equivalent

Criticare Systems, Inc.

FDA 510(k) clearance K942737 for POET IQ WITH FIVE AGENT CAPABILITY, Substantially Equivalent on 1995-02-09. Applicant: Criticare Systems, Inc.. Device class: 2.

Clearance details

Applicant: Criticare Systems, Inc.
Product code: Code CBS
Device class: Class 2
Regulation: 21 CFR 868.1620
Advisory panel: Anesthesiology
Date received: 1994-06-10
Decision date: 1995-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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