AllNEB— 510(k) K242354

Substantially Equivalent

Enchant Tek Co. , Ltd.

FDA 510(k) clearance K242354 for AllNEB, Substantially Equivalent on 2025-04-29. Applicant: Enchant Tek Co. , Ltd..

Clearance details

Applicant: Enchant Tek Co. , Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2024-08-08
Decision date: 2025-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yilan County, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.