Allon 2001
FDA 510(k) K001546 · Mtre Advanced Technology , Ltd.
510(k) numberK001546
Submission
- Device name
- Allon 2001
- Applicant
- Mtre Advanced Technology , Ltd.
Mccordsville, IN, US - Received
- May 18, 2000
- Decision date
- June 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Allon 2001 cleared by the FDA?
Allon 2001 (K001546) received a 510(k) decision of Substantially Equivalent on June 8, 2000, 21 days after the submission was received.
What is the product code of K001546?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.