PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)— 510(k) K944347

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K944347 for PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR), Substantially Equivalent on 1994-12-12. Applicant: Puritan Bennett Corp..

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1994-09-06
Decision date: 1994-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, 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.