MERLIN E-MASK— 510(k) K031397

Substantially Equivalent

Merlin Medical Limited

FDA 510(k) clearance K031397 for MERLIN E-MASK, Substantially Equivalent on 2004-07-29. Applicant: Merlin Medical Limited. Device class: 2.

Clearance details

Applicant: Merlin Medical Limited
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 2003-05-02
Decision date: 2004-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: United Kingdom, GB

Download summary PDF View on FDA.gov ↗

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