GOODKNIGHT 418 CPAP SYSTEM— 510(k) K980365

Substantially Equivalent

Nellcor Puritan Bennett, Inc.

FDA 510(k) clearance K980365 for GOODKNIGHT 418 CPAP SYSTEM, Substantially Equivalent on 1998-07-22. Applicant: Nellcor Puritan Bennett, Inc..

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 1998-01-29
Decision date: 1998-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.