PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM— 510(k) K942210

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K942210 for PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM, Substantially Equivalent on 1996-02-09. Applicant: Puritan Bennett Corp..

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 1994-05-03
Decision date: 1996-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

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.