(MT-27) Thermometer and (M-10PC) Probe Covers
by Sharp Electronics Corp. 510(k)
Active
510(k) K862333
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862333 | Date8 Jul 1986 | 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- Withdrawn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, 28 Sep 2026
The (MT-27) Thermometer is a clinical electronic thermometer used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
The device is supplied with (M-10PC) probe covers and is intended for use in a general hospital setting. It is authorized under FDA 510(k) clearance K862333 with product code FLL. The device may be used with or without disposable probe covers, depending on clinical requirements.
Other devices from Sharp Electronics Corp.
Questions
AI-generated answers, 28 Sep 2026
What is the (MT-27) Thermometer used for?
The (MT-27) Thermometer is a clinical electronic device designed to measure a patient's body temperature by detecting thermal signals via a transducer, which are then amplified, conditioned, and displayed electronically for accurate readings in general hospital settings.
How are the (M-10PC) probe covers supplied with the thermometer?
The (MT-27) Thermometer is supplied with (M-10PC) probe covers as part of the standard package, which are disposable sheaths designed to fit over the transducer probe to maintain hygiene and prevent cross-contamination during patient temperature measurements.
Can the (MT-27) Thermometer be used without disposable probe covers?
Yes, the (MT-27) Thermometer can be used with or without the (M-10PC) disposable probe covers, depending on clinical needs and infection control protocols, as the transducer is designed to function either directly or with a cover in place.