DORNIR LC-1 CPAP SYSTEM— 510(k) K010704

Substantially Equivalent

Prym Medical , Ltd.

FDA 510(k) clearance K010704 for DORNIR LC-1 CPAP SYSTEM, Substantially Equivalent on 2001-04-18. Applicant: Prym Medical , Ltd..

Clearance details

Applicant: Prym Medical , Ltd.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2001-03-09
Decision date: 2001-04-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Ra'Ananna 43373, IL

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.