510(k) K053466— HSINER RESUSCITATOR

Substantially Equivalent

Hsiner Co., Ltd.

Clearance details

Applicant: Hsiner Co., Ltd.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2005-12-13
Decision date: 2006-03-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.