IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
FDA 510(k) clearance K100488 · decided 2010-07-22
Clearance details
- K-number
- K100488
- Device name
- IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-19
- Decision date
- 2010-07-22
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Nanshan District, Shenzhen, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740) recall (Z-0689-2018) | Philips Consumer Lifestyle | 2018-02-22 |