FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Peak Flow Meter
K Number: K241338
·
Decision Dec 31, 2024
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
2
Review Days
232
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Basic Information
- Device Name
- Peak Flow Meter
- K Number
- K241338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chongqing Moffy Innovation Technology Co., Ltd.
- Date Received
- May 13, 2024
- Decision Date
- December 31, 2024
- Product Code
- BZH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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Other Clearances by Chongqing Moffy Innovation Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K240959 | Respiratory Muscle Trainer | Dec 18, 2024 | Substantially Equivalent |