MERLIN RESUSCITATOR— 510(k) K031395

Name: FDA 510(k) clearance K031395
Creator: U.S. Food and Drug Administration
Published: 2004-07-16

Substantially Equivalent

Merlin Medical Limited

FDA 510(k) clearance K031395 for MERLIN RESUSCITATOR, Substantially Equivalent on 2004-07-16. Applicant: Merlin Medical Limited. Device class: 2.

Clearance details

Applicant: Merlin Medical Limited
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 2003-05-02
Decision date: 2004-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: United Kingdom, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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