K240959

Substantially Equivalent

Respiratory Muscle Trainer

Applicant
Chongqing Moffy Innovation Technology Co., Ltd.
Product code
BYI
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chongqing, CN
Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI
Death
3
Total
3

Source: openFDA MAUDE database, through . 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.