The following data is part of a premarket notification filed by Actherm, Inc. with the FDA for Classic/hypothermia, Flexible, 10-second, Left-right Handed, Basal, Lightweight-probe Digital Clinical Thermometer.
| Device ID | K070028 |
| 510k Number | K070028 |
| Device Name: | CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ACTHERM, INC. 6TH F., #85 KUAN-MIN 6 RD. Jubei, Hsinchu, TW 302 |
| Contact | Richard Hsieh |
| Correspondent | Richard Hsieh ACTHERM, INC. 6TH F., #85 KUAN-MIN 6 RD. Jubei, Hsinchu, TW 302 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614801300612 | K070028 | 000 |
| 06972325560122 | K070028 | 000 |
| 06972325560115 | K070028 | 000 |
| 06972325560108 | K070028 | 000 |
| 06972325560092 | K070028 | 000 |
| 06972325560085 | K070028 | 000 |
| 06972325560078 | K070028 | 000 |
| 06972325560061 | K070028 | 000 |
| 06972325560054 | K070028 | 000 |
| 06972325560047 | K070028 | 000 |
| 06972325560030 | K070028 | 000 |
| 06972325560016 | K070028 | 000 |
| 06972325560139 | K070028 | 000 |
| 06972325560146 | K070028 | 000 |
| 06972325560153 | K070028 | 000 |
| 00614801300605 | K070028 | 000 |
| 06972325560252 | K070028 | 000 |
| 06972325560245 | K070028 | 000 |
| 06972325560238 | K070028 | 000 |
| 06972325560221 | K070028 | 000 |
| 06972325560214 | K070028 | 000 |
| 06972325560207 | K070028 | 000 |
| 06972325560191 | K070028 | 000 |
| 06972325560184 | K070028 | 000 |
| 06972325560177 | K070028 | 000 |
| 06972325560160 | K070028 | 000 |
| 06972325560009 | K070028 | 000 |