← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MNS — Ventilator, Continuous, Non-Life-Supporting

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5895
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K251889Resmed Corp · 510k2026-04-08
K252078Compal Electronics, Inc. · 510k2026-03-17
K251661Resmed Pty , Ltd. · 510k2026-02-23
K240778Breas Medical AB · 510k2024-12-13

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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