K240959
- 510(k) number
- K240959
- Device name
- Respiratory Muscle Trainer
- Applicant
- Chongqing Moffy Innovation Technology Co., Ltd. CN
- Product code
- BYI — Percussor, Powered-Electric
- Decision date
- 2024-12-18
- Date received
- 2024-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240959
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.