Therm-X
FDA 510(k) clearance K190854 · decided 2019-05-10
Clearance details
- K-number
- K190854
- Device name
- Therm-X
- Applicant
- Zenith Technical Innovations
- Decision
- Substantially Equivalent
- Date received
- 2019-04-02
- Decision date
- 2019-05-10
- Days to decision
- 38 days
- Clearance type
- Abbreviated
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Gurnee, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.