Micro Therm MT-500 & MT-600
by Medequi, Division of King Yip Co., Inc.
510(k) K854035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854035 | Date12 Nov 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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, 24 Sep 2026
The Micro Therm MT-500 & MT-600 is a medical device classified under product code FLL for general hospital use. It is a substantially equivalent device that falls under the regulation number 880.2910.
The device is manufactured by Medequi, Division of King Yip Co., Inc. and received FDA 510(k) clearance on November 12, 1985, with K number K854035. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the data.
Other devices from Medequi, Division of King Yip Co., Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the Micro Therm MT-500 & MT-600 used for?
The Micro Therm MT-500 & MT-600 is a medical device classified under product code FLL for general hospital use. It is a substantially equivalent device that falls under regulation number 880.2910.
What is the regulatory status of the Micro Therm MT-500 & MT-600?
The device received FDA 510(k) clearance on November 12, 1985, with K number K854035. It is classified as substantially equivalent under decision code SESE.
Who manufactures the Micro Therm MT-500 & MT-600?
The Micro Therm MT-500 & MT-600 is manufactured by Medequi, Division of King Yip Co., Inc., located in Los Angeles, California.
Is the Micro Therm MT-500 & MT-600 sterile or single-use?
No information regarding sterility, single-use or reusable status is provided in the available device data.