510(k) K964719— HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR

Substantially Equivalent

Hudson Respiratory Care, Inc.

Clearance details

Applicant: Hudson Respiratory Care, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1996-11-25
Decision date: 1997-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, 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.