SMARTMONITOR 2, MODEL 4000— 510(k) K011597

Name: FDA 510(k) clearance K011597
Creator: U.S. Food and Drug Administration
Published: 2002-01-11

Substantially Equivalent

Respironics Georgia, Inc.

FDA 510(k) clearance K011597 for SMARTMONITOR 2, MODEL 4000, Substantially Equivalent on 2002-01-11. Applicant: Respironics Georgia, Inc.. Device class: 2.

Clearance details

Applicant: Respironics Georgia, Inc.
Product code: Code FLS
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 2001-05-24
Decision date: 2002-01-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

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