The following data is part of a premarket notification filed by Oriental Inspiration Ltd with the FDA for Ir Forehead Thermometer, Model Hv-t36.
| Device ID | K032612 |
| 510k Number | K032612 |
| Device Name: | IR FOREHEAD THERMOMETER, MODEL HV-T36 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ORIENTAL INSPIRATION LTD 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour ORIENTAL INSPIRATION LTD 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-25 |
| Decision Date | 2004-02-19 |
| Summary: | summary |