The following data is part of a premarket notification filed by Actherm, Inc. with the FDA for Actherm Infrared Ear Thermometer Act 8000r Series And Its Probe Cover Med Accu2010.
| Device ID | K093795 |
| 510k Number | K093795 |
| Device Name: | ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ACTHERM, INC. 6F, NO.18 JHANYE 2ND RD., HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Contact | Richard Hsieh |
| Correspondent | Richard Hsieh ACTHERM, INC. 6F, NO.18 JHANYE 2ND RD., HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-10 |
| Decision Date | 2010-03-12 |
| Summary: | summary |