INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400— 510(k) K011344

Name: FDA 510(k) clearance K011344
Creator: U.S. Food and Drug Administration
Published: 2002-05-17

Substantially Equivalent

Collins Medical, Inc.

FDA 510(k) clearance K011344 for INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400, Substantially Equivalent on 2002-05-17. Applicant: Collins Medical, Inc.. Device class: 2.

Clearance details

Applicant: Collins Medical, Inc.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 2001-05-02
Decision date: 2002-05-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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