The following data is part of a premarket notification filed by Jinxinbao Electronic Co.,ltd with the FDA for Non-contact Infrared Thermometer.
| Device ID | K130231 |
| 510k Number | K130231 |
| Device Name: | NON-CONTACT INFRARED THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | JINXINBAO ELECTRONIC CO.,LTD ROOM 404, BLDG 7, JINHUICHANG HOMELAND LIUHONGQIAO RD. Wenzhou, Zhejiang, CN 325000 |
| Contact | Helen Nan |
| Correspondent | Helen Nan JINXINBAO ELECTRONIC CO.,LTD ROOM 404, BLDG 7, JINHUICHANG HOMELAND LIUHONGQIAO RD. Wenzhou, Zhejiang, CN 325000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-10-15 |
| Summary: | summary |