COSMED PONY FX— 510(k) K040549

Substantially Equivalent

Cosmed Srl

FDA 510(k) clearance K040549 for COSMED PONY FX, Substantially Equivalent on 2004-09-28. Applicant: Cosmed Srl. Device class: 2.

Clearance details

Applicant: Cosmed Srl
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2004-03-02
Decision date: 2004-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.