BREATH SHAKE— 510(k) K121587

Substantially Equivalent

Cheen Houng Ent. Co. , Ltd.

FDA 510(k) clearance K121587 for BREATH SHAKE, Substantially Equivalent on 2013-11-22. Applicant: Cheen Houng Ent. Co. , Ltd..

Clearance details

Applicant: Cheen Houng Ent. Co. , Ltd.
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2012-05-31
Decision date: 2013-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.