FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
TD-7301 Spirometer (TD-7301)
K Number: K241843
·
Decision Nov 20, 2024
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
3
Review Days
147
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Basic Information
- Device Name
- TD-7301 Spirometer (TD-7301)
- K Number
- K241843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gostar Co., Ltd.
- Date Received
- June 26, 2024
- Decision Date
- November 20, 2024
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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