The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd with the FDA for Infrared Thermometer.
| Device ID | K182597 |
| 510k Number | K182597 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Pango Electronic Co., Ltd No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village Henggang Town Shenzhen, CN 518115 |
| Contact | Youjian Xie |
| Correspondent | Chengyu Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 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 | 2018-09-20 |
| Decision Date | 2019-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50860001625832 | K182597 | 000 |
| 00628678770188 | K182597 | 000 |
| 10031262101249 | K182597 | 000 |
| G025PGIRT16020 | K182597 | 000 |
| 00860004898610 | K182597 | 000 |
| 00860004898627 | K182597 | 000 |
| 00860004330691 | K182597 | 000 |
| 00372217003021 | K182597 | 000 |
| 00856324008297 | K182597 | 000 |
| 00817076010952 | K182597 | 000 |
| 06948423808763 | K182597 | 000 |
| 06948423808817 | K182597 | 000 |
| 06948423808824 | K182597 | 000 |
| 00860002217222 | K182597 | 000 |
| 00031262101358 | K182597 | 000 |