The following data is part of a premarket notification filed by Rycom Electron Technology Limited with the FDA for Remote Infrared Thermometer, Model Rc002.
| Device ID | K090361 |
| 510k Number | K090361 |
| Device Name: | REMOTE INFRARED THERMOMETER, MODEL RC002 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RYCOM ELECTRON TECHNOLOGY LIMITED SUITE 8D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong RYCOM ELECTRON TECHNOLOGY LIMITED SUITE 8D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai, CN 200030 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-12 |
| Decision Date | 2009-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816703029916 | K090361 | 000 |
| 00816703024751 | K090361 | 000 |