INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
FDA 510(k) clearance K081788 · decided 2008-12-17
Clearance details
- K-number
- K081788
- Device name
- INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
- Applicant
- Innochips Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-24
- Decision date
- 2008-12-17
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Buena Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.