NEONATALIE RESUSCITATOR— 510(k) K132172

Name: FDA 510(k) clearance K132172
Creator: U.S. Food and Drug Administration
Published: 2015-01-15

Substantially Equivalent

Laerdal Medical A/S

FDA 510(k) clearance K132172 for NEONATALIE RESUSCITATOR, Substantially Equivalent on 2015-01-15. Applicant: Laerdal Medical A/S. Device class: 2.

Clearance details

Applicant: Laerdal Medical A/S
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 2013-07-15
Decision date: 2015-01-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Stavanger, NO

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.