The following data is part of a premarket notification filed by Famidoc Technology Co., Ltd with the FDA for Infrared Thermometer, Fdir-v1.
| Device ID | K052849 |
| 510k Number | K052849 |
| Device Name: | INFRARED THERMOMETER, FDIR-V1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FAMIDOC TECHNOLOGY CO., LTD 3RD FLOOR, EAST BLOCK 4 CHEGONGMIAO ANHUA INDUST. ZONE Schenzhen, Guangdong, CN |
| Contact | Mr. Steeljin |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2005-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970389631017 | K052849 | 000 |
| 00897429002056 | K052849 | 000 |