FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Therm-X (Home); Therm-X (AT)
K Number: K240125
·
Decision Jun 21, 2024
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
5
Review Days
157
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Basic Information
- Device Name
- Therm-X (Home); Therm-X (AT)
- K Number
- K240125
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zenith Technical Innovations
- Date Received
- January 16, 2024
- Decision Date
- June 21, 2024
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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