510(k) K023494— NELLCOR INDGO MANUAL RESUSCITATOR

Substantially Equivalent

Nellcor Puritan Bennett, Inc.

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2002-10-18
Decision date: 2003-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

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.