SMARTMONITOR 2 PROFESSIONAL SERIES (PS)— 510(k) K032403

Name: FDA 510(k) clearance K032403
Creator: U.S. Food and Drug Administration
Published: 2003-10-27

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K032403 for SMARTMONITOR 2 PROFESSIONAL SERIES (PS), Substantially Equivalent on 2003-10-27. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant: Respironics, Inc.
Product code: Code NPF
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 2003-08-04
Decision date: 2003-10-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

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