The following data is part of a premarket notification filed by Chogqing Yuhe Medical Instruments Co., Ltd. with the FDA for Bashan Tdp Heat Lamp.
| Device ID | K162590 |
| 510k Number | K162590 |
| Device Name: | Bashan TDP Heat Lamp |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | Chogqing YUHE Medical Instruments Co., Ltd. No.104-8 City Garden Mid Road, Shapingba District Chongqing, CN 400038 |
| Contact | Liu Yong |
| Correspondent | Liu Yong Chogqing YUHE Medical Instruments Co., Ltd. No.104-8 City Garden Mid Road, Shapingba District Chongqing, CN 400038 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-16 |
| Decision Date | 2017-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970567470162 | K162590 | 000 |
| 06970567470155 | K162590 | 000 |