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Somnera System Nasal Pillow

FRESCA MEDICAL, INC. · Model 60942 · UDI-DI 30810045450163

QBY Prescription
1
510(k) clearances
2
Adverse events
0
Recalls
1
Facilities

Description

A positive airway pressure system for the treatment of obstructive sleep apnea. System consists of an airflow generator, mask, headgear, valve and hose.

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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.