The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd. with the FDA for Infrared Thermometer.
Device ID | K203454 |
510k Number | K203454 |
Device Name: | Infrared Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Shandong Zhushi Pharmaceutical Group Co., Ltd. No.6 Shande Road, Shan Country Heze, CN 274300 |
Contact | Junhui Zhu |
Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-23 |
Decision Date | 2021-04-29 |