The following data is part of a premarket notification filed by Choice Smart Health Care Co. Ltd. with the FDA for Infrared Ear Thermometer, Model Irt-21 And Irt-22.
| Device ID | K063291 |
| 510k Number | K063291 |
| Device Name: | INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | CHOICE SMART HEALTH CARE CO. LTD. 2108 CIRO'S PLAZA 388 WEST NANJING ROAD Shanghai, CN 200003 |
| Contact | Janice Ma |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2006-11-21 |
| Summary: | summary |