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FDA PRODUCT CODE · CLASS II

OQU — Airway Monitoring System

The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5730
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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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