Respiratory Muscle Trainer— 510(k) K240959

Substantially Equivalent

Chongqing Moffy Innovation Technology Co., Ltd.

FDA 510(k) clearance K240959 for Respiratory Muscle Trainer, Substantially Equivalent on 2024-12-18. Applicant: Chongqing Moffy Innovation Technology Co., Ltd..

Clearance details

Applicant
Chongqing Moffy Innovation Technology Co., Ltd.
Product code
Code BYI
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chongqing, CN
Download summary PDFView 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.