Disposable Temperature Probe
by Shenzhen Caremed Medical Technology Co., Ltd.
510(k) K182755
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182755 | Date21 Dec 2018 | StatusActive |
Official records
- FDA 510(k) database K182755
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 19 Sep 2026
The Disposable Temperature Probe is a medical device designed for measuring body temperature. It is intended for use in clinical settings to provide accurate and reliable temperature readings.
The probe is supplied sterile and is intended for single-use to ensure hygiene and prevent cross-contamination. It is compatible with various monitoring systems and is regulated under FDA 510(k) authorization. Proper storage conditions should be maintained to ensure device integrity.
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- Welch Allyn, Inc. 901010 02893-000 by Welch Allyn, Inc.
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