The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Ir Ear/forehead Thermometer Mode Dx6635, Dx6637, Dth1081.
| Device ID | K100488 |
| 510k Number | K100488 |
| Device Name: | IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. ESTAE XILIXIAOBAIMANG Nanshan District, Shenzhen, CN 518108 |
| Contact | Zhigang Zhao |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-19 |
| Decision Date | 2010-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917199303 | K100488 | 000 |
| 00845717010016 | K100488 | 000 |
| 10891040702033 | K100488 | 000 |
| 20891040701200 | K100488 | 000 |
| 10891040701197 | K100488 | 000 |
| 10041260367066 | K100488 | 000 |
| 10036800398297 | K100488 | 000 |
| 10021130771292 | K100488 | 000 |
| 00080196406404 | K100488 | 000 |
| 06926408700011 | K100488 | 000 |
| 20075020053293 | K100488 | 000 |
| 10614299013473 | K100488 | 000 |
| 10767056189352 | K100488 | 000 |
| 10767056185453 | K100488 | 000 |
| 10767056182254 | K100488 | 000 |
| 10767056182100 | K100488 | 000 |
| 10767056131320 | K100488 | 000 |
| 00816479015281 | K100488 | 000 |
| 00075020054043 | K100488 | 000 |
| 20311917010797 | K100488 | 000 |