The following data is part of a premarket notification filed by Shenzhen Pacom Medical Instruments Co., Ltd. with the FDA for Infrared Thermometer.
| Device ID | K172889 |
| 510k Number | K172889 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Pacom Medical Instruments Co., Ltd. 8 Floor, B District, B Building, No. 5 Industry Five Road, Jianbian Community, Songgang Shenzhen, CN 518105 |
| Contact | Liangzhou Zhong |
| Correspondent | Liangzhou Zhong Shenzhen Pacom Medical Instruments Co., Ltd. 8 Floor, B District, B Building, No. 5 Industry Five Road, Jianbian Community, Songgang Shenzhen, CN 518105 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-21 |
| Decision Date | 2018-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859811007360 | K172889 | 000 |
| 10840061482905 | K172889 | 000 |
| 10840061482813 | K172889 | 000 |
| 00840061482823 | K172889 | 000 |
| 10840061486828 | K172889 | 000 |
| 10840061486811 | K172889 | 000 |
| 10840061482806 | K172889 | 000 |
| 10840061486804 | K172889 | 000 |
| 08400614000007 | K172889 | 000 |
| 10840061482837 | K172889 | 000 |