AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS— 510(k) K042843

Substantially Equivalent

Ambu, Inc.

FDA 510(k) clearance K042843 for AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS, Substantially Equivalent on 2004-11-12. Applicant: Ambu, Inc..

Clearance details

Applicant: Ambu, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2004-10-14
Decision date: 2004-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linthicum, MD, US

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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.