DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES
FDA 510(k) clearance K092557 · decided 2009-12-17
Clearance details
- K-number
- K092557
- Device name
- DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES
- Applicant
- Harvard Medical Devices , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-20
- Decision date
- 2009-12-17
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tsimshatsui, Kowloon, HK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.