Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator— 510(k) K152931

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K152931 for Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator, Substantially Equivalent on 2016-08-29. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2015-10-05
Decision date: 2016-08-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

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.