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 |