FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLON 2001 MODIFIED
K Number: K003349
·
Decision Nov 13, 2000
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
6
Review Days
18
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ALLON 2001 MODIFIED
- K Number
- K003349
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mtre Advanced Technology , Ltd.
- Date Received
- October 26, 2000
- Decision Date
- November 13, 2000
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWJ), ordered by most recent decision date.
Hot Pink Pad Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Temperature Management System (Model 5000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Celsi Warmer
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Stat Temperature Management System
FDA 510(k)
FDA Class 2
·Cardiovascular
HotDog Warming Mattress + Return Electrode
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Mtre Advanced Technology , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K102112 | CRITICOOL PRO | Nov 18, 2010 | Substantially Equivalent |
| K083662 | CRITICOOL | Mar 26, 2009 | Substantially Equivalent |
| K024128 | ALLON 2001 VERSION 5 | Feb 10, 2003 | Substantially Equivalent |
| K001546 | ALLON 2001 | Jun 8, 2000 | Substantially Equivalent |
| K992386 | ALLON 2000 | Mar 7, 2000 | Substantially Equivalent |