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FDA PRODUCT CODE · CLASS II

BZE — Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5270
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K252066Vincent Healthcare Products Limited · 510k2026-06-18
K253322Medline Industries, LP · 510k2026-03-25
K243244Guangdong Eda Technology Co., Ltd. · 510k2025-07-25

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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