The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Infrared Thermometer.
| Device ID | K182133 |
| 510k Number | K182133 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen AOJ Medical Technology Co., Ltd. Room 202, HaoGu Industry Park, 2037 Guanguang Road, Guangming District Shenzhen, CN 518103 |
| Contact | Qihuan Zhao |
| Correspondent | Qihuan Zhao Shenzhen AOJ Medical Technology Co., Ltd. Room 202, HaoGu Industry Park, 2037 Guanguang Road, Guangming District Shenzhen, CN 518103 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2018-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972040110022 | K182133 | 000 |
| 00863850000329 | K182133 | 000 |
| 06972040110510 | K182133 | 000 |
| 06972040110503 | K182133 | 000 |
| 06972040110497 | K182133 | 000 |
| 06972040110480 | K182133 | 000 |
| 06972040110398 | K182133 | 000 |
| 06972040110350 | K182133 | 000 |
| 06972040110343 | K182133 | 000 |
| 06972040110329 | K182133 | 000 |
| 06972040110282 | K182133 | 000 |
| 06972040110220 | K182133 | 000 |
| 06972040110213 | K182133 | 000 |
| 06972040110008 | K182133 | 000 |
| 00810028770614 | K182133 | 000 |
| 06972040110589 | K182133 | 000 |
| 06972040110558 | K182133 | 000 |
| 06972040110039 | K182133 | 000 |
| 06972040110046 | K182133 | 000 |
| 06972040110015 | K182133 | 000 |
| 09354754000016 | K182133 | 000 |
| 06972040110312 | K182133 | 000 |
| 06972040110305 | K182133 | 000 |
| 06972040110268 | K182133 | 000 |
| 06972040110206 | K182133 | 000 |
| 06972040110190 | K182133 | 000 |
| 06972040110183 | K182133 | 000 |
| 06972040110169 | K182133 | 000 |
| 06972040110152 | K182133 | 000 |
| 06972040110145 | K182133 | 000 |
| 06972040110138 | K182133 | 000 |
| 06972040110121 | K182133 | 000 |
| 06972040110114 | K182133 | 000 |
| 06972040110107 | K182133 | 000 |
| 06972040110091 | K182133 | 000 |
| 00041220874361 | K182133 | 000 |