FEMON Banana Thermometer
FDA 510(k) clearance K180767 · decided 2019-01-22
Clearance details
- K-number
- K180767
- Device name
- FEMON Banana Thermometer
- Applicant
- Life Science Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-23
- Decision date
- 2019-01-22
- Days to decision
- 305 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.