COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM— 510(k) K910194

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K910194 for COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM, Substantially Equivalent on 1991-05-13. Applicant: Puritan Bennett Corp..

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 1991-01-16
Decision date: 1991-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

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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.