The following data is part of a premarket notification filed by Actherm, Inc. with the FDA for Actherm Digital Clinical Thermometer, Models Act2000, Act2010, Act2000+, Act2010+, Act2020+.
| Device ID | K010238 |
| 510k Number | K010238 |
| Device Name: | ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ACTHERM, INC. 10TH F. #43 KUAN-MIN 6 ROAD Jubei, Hsinchu, TW 302 |
| Contact | Richard Hsieh |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-01-25 |
| Decision Date | 2001-02-06 |