Allon 2001 Version 5
by Mtre Advanced Technology, Ltd.
510(k) K024128
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK024128 | Date10 Feb 2003 | StatusActive |
Recalls
-
- Ongoing Z-1966-2025
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DWJ
- FDA applicant
- Mtre Advanced Technology , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5900
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent