Data / Medical devices / Standard Polysomnograph With Electroencephalograph

Standard Polysomnograph With Electroencephalograph (OLV): 38 FDA-registered makers in 12 countries

38 establishments in 12 countries are registered with the FDA to make Standard Polysomnograph With Electroencephalograph (product code OLV, Class 2, 21 CFR 882.1400). 18 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 65 510(k) clearances under this code, the latest on August 25, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

OLV

Device class

2

Regulation

882.1400

Medical specialty

Neurology

Makers by country

Makers of Standard Polysomnograph With Electroencephalograph

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated August 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.