MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS— 510(k) K903438

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K903438 for MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS, Substantially Equivalent on 1990-08-17. Applicant: Puritan Bennett Corp..

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1990-07-31
Decision date: 1990-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.