FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Pulmonary Function Tester, Model: A9
K Number: K231561
·
Decision Feb 21, 2024
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
2
Review Days
266
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Basic Information
- Device Name
- Pulmonary Function Tester, Model: A9
- K Number
- K231561
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guangzhou Homesun Medical Technology Co., Ltd.
- Date Received
- May 31, 2023
- Decision Date
- February 21, 2024
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
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Other Clearances by Guangzhou Homesun Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K191239 | Smart Peak Flow Meter | Dec 6, 2019 | Substantially Equivalent |