The following data is part of a premarket notification filed by Guangzhou Berrcom Medical Device Co., Ltd. with the FDA for Ear Thermometer, Model Et005, Et008, Et009.
| Device ID | K213084 |
| 510k Number | K213084 |
| Device Name: | Ear Thermometer, Model ET005, ET008, ET009 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Guangzhou Berrcom Medical Device Co., Ltd. No.38 Huanzhen Xi Road, Dagang Town, Nansha Guangzhou, CN 51147 |
| Contact | Zhigang Du |
| Correspondent | Yoyo Chen Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, CN 518000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-23 |
| Decision Date | 2022-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 56947656114691 | K213084 | 000 |