The following data is part of a premarket notification filed by Shenzhen Jumper Medical Equipment Co., Ltd. with the FDA for Infrared Thermometer.
Device ID | K172795 |
510k Number | K172795 |
Device Name: | Infrared Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Shenzhen Jumper Medical Equipment Co., Ltd. D Building, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen, Guangdong Shenzhen, CN 518102 |
Contact | Rambo Yang |
Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd Shizhou Middle Shenzhen, CN Gd755 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-15 |
Decision Date | 2018-03-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00667673872916 | K172795 | 000 |
08719481722067 | K172795 | 000 |
06951740500548 | K172795 | 000 |
06951740500531 | K172795 | 000 |
08719699636477 | K172795 | 000 |
10891040000269 | K172795 | 000 |
08719699636552 | K172795 | 000 |
06951740500494 | K172795 | 000 |
00682891111159 | K172795 | 000 |
00867661000370 | K172795 | 000 |
08719699636217 | K172795 | 000 |
00869378000421 | K172795 | 000 |
06951740512800 | K172795 | 000 |
08719699630475 | K172795 | 000 |
08719699630185 | K172795 | 000 |
08719699632721 | K172795 | 000 |
10856471007171 | K172795 | 000 |
08719699633315 | K172795 | 000 |
08719699636248 | K172795 | 000 |
08719699636729 | K172795 | 000 |