BIVONA SLEEP APNEA TUBE— 510(k) K915799

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K915799 for BIVONA SLEEP APNEA TUBE, Substantially Equivalent on 1992-02-03. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1991-12-24
Decision date: 1992-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.