FLEXI-LITE, MODEL FL-V1.2— 510(k) K051759

Substantially Equivalent

Performance Hyperbarics

FDA 510(k) clearance K051759 for FLEXI-LITE, MODEL FL-V1.2, Substantially Equivalent on 2005-11-17. Applicant: Performance Hyperbarics.

Clearance details

Applicant: Performance Hyperbarics
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 2005-06-29
Decision date: 2005-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Makawao, HI, US

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Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

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.