← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LEL — Device, Sleep Assessment

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5050
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K252981Empatica S.r.l. · 510k2025-12-22
K251574Ambulatory Monitoring, Inc. · 510k2025-07-31
K243513Pneumowave, Ltd. · 510k2025-04-16

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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