The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Non-contact Forehead Thermometer.
Device ID | K161735 |
510k Number | K161735 |
Device Name: | Non-contact Forehead Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
Contact | Siping Yuan |
Correspondent | Siping Yuan Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-23 |
Decision Date | 2016-11-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816479015601 | K161735 | 000 |
06926408700165 | K161735 | 000 |
16926408700209 | K161735 | 000 |
06926408700455 | K161735 | 000 |
20311917221384 | K161735 | 000 |
10891040701173 | K161735 | 000 |
20311917047212 | K161735 | 000 |