COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
FDA 510(k) clearance K182652 · decided 2018-11-20
Clearance details
- K-number
- K182652
- Device name
- COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
- Applicant
- Kangfu Medical Equipment Factory
- Decision
- Substantially Equivalent
- Date received
- 2018-09-24
- Decision date
- 2018-11-20
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Yueqing City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.