INFRARED EAR THERMOMETER, MODEL ET-101A
FDA 510(k) clearance K082192 · decided 2008-09-17
Clearance details
- K-number
- K082192
- Device name
- INFRARED EAR THERMOMETER, MODEL ET-101A
- Applicant
- Sejoy Electronics & Instruments Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-04
- Decision date
- 2008-09-17
- Days to decision
- 44 days
- Clearance type
- Abbreviated
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hangzhou, Zhejiang, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.