The following data is part of a premarket notification filed by Philips Electronics Uk Limited with the FDA for Philips Avent Digital Thermometer Set, Model Sch540.
| Device ID | K100495 |
| 510k Number | K100495 |
| Device Name: | PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | PHILIPS ELECTRONICS UK LIMITED LOWER ROAD Glemsford, Suffolk, GB Co10 7qs |
| Contact | Miriam Sharif-murray |
| Correspondent | Miriam Sharif-murray PHILIPS ELECTRONICS UK LIMITED LOWER ROAD Glemsford, Suffolk, GB Co10 7qs |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-19 |
| Decision Date | 2010-06-22 |