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Polysmith Sleep System

NIHON KOHDEN AMERICA, INC. · Model A/ONEBED-SCORE-11X · UDI-DI 00841983104008

OLTOLV Prescription
10
510(k) clearances
35
Adverse events (2 deaths)
0
Recalls
67
Facilities

Description

Polysomnography Sleep System Version 11

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.