The following data is part of a premarket notification filed by Shenzhen Caremed Medical Technology Co., Ltd. with the FDA for Disposable Temperature Probe.
| Device ID | K182755 |
| 510k Number | K182755 |
| Device Name: | Disposable Temperature Probe |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Caremed Medical Technology Co., Ltd. East Side, 3/F, C Building, Kelunte Low-Carbon Industries Gaofeng Community Dalang Office, Longhua District, Shenzhe, CN 518109 |
| Contact | Alan Xie |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, CN 518067 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2018-12-21 |
| Summary: | summary |