← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OLV — Standard Polysomnograph With Electroencephalograph

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.1400
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K260585Nox Medical Ehf · 510k2026-03-20
K242447Compumedics Limited · 510k2025-02-20
K241288Nox Medical Ehf · 510k2024-12-23
K240700Somnomedics GmbH · 510k2024-12-08

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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