STB GUEDEL AIRWAY— 510(k) K933760

Substantially Equivalent

Save-T-Breath Distributors C.C.

FDA 510(k) clearance K933760 for STB GUEDEL AIRWAY, Substantially Equivalent on 1994-03-23. Applicant: Save-T-Breath Distributors C.C..

Clearance details

Applicant: Save-T-Breath Distributors C.C.
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 1993-08-03
Decision date: 1994-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Africa, ZA

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Adverse events under product code CAE

product code CAE

Death: 4
Total: 4

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.