The following data is part of a premarket notification filed by Guangzhou Jinxinbao Electronic Co., Ltd with the FDA for Digital Thermometer.
Device ID | K163603 |
510k Number | K163603 |
Device Name: | Digital Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Guangzhou Jinxinbao Electronic Co., Ltd No.38 Huanzhen Xi Road, Dagang Town, Nansha Distric Guangzhou, CN 511470 |
Contact | Mowu Zhu |
Correspondent | Elly Xu Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre Shenzhen, TW 518101 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-21 |
Decision Date | 2017-06-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856324008136 | K163603 | 000 |
20085239956964 | K163603 | 000 |
20810125111888 | K163603 | 000 |
06947656112784 | K163603 | 000 |
66947656114087 | K163603 | 000 |
66947656114094 | K163603 | 000 |
20810125112885 | K163603 | 000 |
66947656113646 | K163603 | 000 |
00810003751850 | K163603 | 000 |
06947656112135 | K163603 | 000 |
06947656112142 | K163603 | 000 |
00085239956632 | K163603 | 000 |