DMR PLUS DISPOSABLE MANUAL RESUSCITATOR— 510(k) K973419

Substantially Equivalent

Nellcor Puritan Bennett, Inc.

FDA 510(k) clearance K973419 for DMR PLUS DISPOSABLE MANUAL RESUSCITATOR, Substantially Equivalent on 1998-03-25. Applicant: Nellcor Puritan Bennett, Inc..

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1997-09-10
Decision date: 1998-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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.