THERMOFLASH LX-26
FDA 510(k) clearance K080759 · decided 2008-05-12
Clearance details
- K-number
- K080759
- Device name
- THERMOFLASH LX-26
- Applicant
- Jxb Co. Ltd Guangzhou (China)
- Decision
- Substantially Equivalent
- Date received
- 2008-03-18
- Decision date
- 2008-05-12
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Panuy, Guangzhou, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.