The following data is part of a premarket notification filed by Shenzhen Pango Medical Electronics Co., Ltd. with the FDA for Infrared Thermometer, Model: Pg-irt1612, Pg-irt1613, Pg-irt1615, Pg-irt1618.
| Device ID | K212346 |
| 510k Number | K212346 |
| Device Name: | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Pango Medical Electronics Co., Ltd. No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village Henggang Town, Longgang District Shenzhen, CN 518115 |
| Contact | Youjian Xie |
| Correspondent | Diana Hong 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 | 2021-07-28 |
| Decision Date | 2022-05-05 |