The following data is part of a premarket notification filed by Sejoy Electronics & Instruments Co., Ltd. with the FDA for Infrared Ear Thermometer, Model Et-101a.
| Device ID | K082192 |
| 510k Number | K082192 |
| Device Name: | INFRARED EAR THERMOMETER, MODEL ET-101A |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. 4TH FLOOR, B2 BUILDING FENG-TAN-LU INDUSTRIAL ZONE Hangzhou, Zhejiang, CN 310030 |
| Contact | Ren Yunhua |
| Correspondent | Tzu-wei Li CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu,, TW |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-04 |
| Decision Date | 2008-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20370393420018 | K082192 | 000 |