AMBU TWIN PUMP - (MANUAL SUCTION PUMP)— 510(k) K883433

Substantially Equivalent

Ambu, Inc.

FDA 510(k) clearance K883433 for AMBU TWIN PUMP - (MANUAL SUCTION PUMP), Substantially Equivalent on 1988-09-02. Applicant: Ambu, Inc..

Clearance details

Applicant: Ambu, Inc.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1988-08-15
Decision date: 1988-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanover, MD, US

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.