Philips Avent Digital Thermometer Set, Model SCH540
by Philips Electronics UK Limited 510(k)
Active
510(k) K100495
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100495 | Date22 Jun 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Philips Avent Digital Thermometer Set, Model SCH540 is a digital thermometer set designed for measuring body temperature. It is a substantially equivalent device cleared through the FDA 510(k) process under product code FLL.
This device is supplied as a set and is intended for general hospital use. It is a reusable device that requires appropriate cleaning and disinfection between uses. Storage and handling should follow manufacturer guidelines, and it is not MRI conditional unless explicitly stated in the specifications.
Other devices from Philips Electronics UK Limited
Questions
AI-generated answers, 23 Sep 2026
What is the Philips Avent Digital Thermometer Set, Model SCH540 used for?
The Philips Avent Digital Thermometer Set, Model SCH540 is designed for measuring body temperature and is intended for general hospital use as a reusable device that requires appropriate cleaning and disinfection between uses.
How is the Philips Avent Digital Thermometer Set, Model SCH540 supplied and is it reusable?
The device is supplied as a set and is explicitly described as reusable, meaning it can be used multiple times provided it undergoes appropriate cleaning and disinfection between each use according to manufacturer guidelines.
What are the storage and handling requirements for the Philips Avent Digital Thermometer Set, Model SCH540?
Storage and handling should follow the manufacturer's guidelines, and the device is not MRI conditional unless explicitly stated in the specifications, which it is not in the provided data.