The following data is part of a premarket notification filed by Mtre Advanced Technology Ltd. with the FDA for Allon 2001.
| Device ID | K001546 |
| 510k Number | K001546 |
| Device Name: | ALLON 2001 |
| Classification | System, Thermal Regulating |
| Applicant | MTRE ADVANCED TECHNOLOGY LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MTRE ADVANCED TECHNOLOGY LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-18 |
| Decision Date | 2000-06-08 |