The following data is part of a premarket notification filed by Shenzhen Pacom Medical Instruments Co., Ltd. with the FDA for Infrared Thermometer, Model: Pc808.
| Device ID | K190717 |
| 510k Number | K190717 |
| Device Name: | Infrared Thermometer, Model: PC808 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Pacom Medical Instruments Co., Ltd. 8th Floor Of B District, B Building, No.5, Industry Five road, Jianbian Community Shenzhen, CN 518105 |
| Contact | Xuewen Chen |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen, CN 518000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-20 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840061480904 | K190717 | 000 |
| 10840061480116 | K190717 | 000 |
| 10840061481601 | K190717 | 000 |