RTX RESPIRATOR— 510(k) K082657

Substantially Equivalent

Medivent Limited

FDA 510(k) clearance K082657 for RTX RESPIRATOR, Substantially Equivalent on 2008-10-08. Applicant: Medivent Limited. Device class: 2.

Clearance details

Applicant: Medivent Limited
Product code: Code BYT
Device class: Class 2
Regulation: 21 CFR 868.5935
Advisory panel: Anesthesiology
Date received: 2008-09-12
Decision date: 2008-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, England, GB

Download summary PDF View on FDA.gov ↗

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