The following data is part of a premarket notification filed by Chongqing Xinfeng Medical Instruments Co., Ltd. with the FDA for Xinfeng Heat Lamps, Models, Cq-27,cq-36, Cq-55, Cq-55a.
| Device ID | K043558 |
| 510k Number | K043558 |
| Device Name: | XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD. 1800 CENTURY PARK E, STE 600 Century City, CA 90067 |
| Contact | George Su |
| Correspondent | George Su CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD. 1800 CENTURY PARK E, STE 600 Century City, CA 90067 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16970469760047 | K043558 | 000 |
| 16970469760030 | K043558 | 000 |