The following data is part of a premarket notification filed by Acute Ideas Co. Ltd. with the FDA for Digital Thermometer Classic Type And Flexible Type.
| Device ID | K023711 |
| 510k Number | K023711 |
| Device Name: | DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ACUTE IDEAS CO. LTD. 3F,NO.11,LANE 35, JIHU ROAD NEIHU DIST., Taipei, TW 114 |
| Contact | Albert Chen |
| Correspondent | Albert Chen ACUTE IDEAS CO. LTD. 3F,NO.11,LANE 35, JIHU ROAD NEIHU DIST., Taipei, TW 114 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-04 |
| Decision Date | 2002-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30048526007197 | K023711 | 000 |