AMBU HAND POWER SUCTION PUMP— 510(k) K992902

Substantially Equivalent

Ambu, Inc.

FDA 510(k) clearance K992902 for AMBU HAND POWER SUCTION PUMP, Substantially Equivalent on 1999-10-25. Applicant: Ambu, Inc..

Clearance details

Applicant: Ambu, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1999-08-30
Decision date: 1999-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linthicum, MD, US

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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.