Respiratory Muscle Trainer
FDA 510(k) K240959 · Chongqing Moffy Innovation Technology Co., Ltd.
510(k) numberK240959
Submission
- Device name
- Respiratory Muscle Trainer
- Applicant
- Chongqing Moffy Innovation Technology Co., Ltd.
Chongqing, CN - Received
- April 8, 2024
- Decision date
- December 18, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYI – Percussor, Powered-Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5665
- Specialty
- Anesthesiology
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Questions and answers
When was Respiratory Muscle Trainer cleared by the FDA?
Respiratory Muscle Trainer (K240959) received a 510(k) decision of Substantially Equivalent on December 18, 2024, 254 days after the submission was received.
What is the product code of K240959?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.