The following data is part of a premarket notification filed by Mtre Advanced Technology Ltd. with the FDA for Allon 2001 Version 5.
| Device ID | K024128 |
| 510k Number | K024128 |
| Device Name: | ALLON 2001 VERSION 5 |
| Classification | System, Thermal Regulating |
| Applicant | MTRE ADVANCED TECHNOLOGY LTD. 6052 WILMINGTON PIKE #225 Centerville, OH 45459 |
| Contact | Douglas Rash |
| Correspondent | Douglas Rash MTRE ADVANCED TECHNOLOGY LTD. 6052 WILMINGTON PIKE #225 Centerville, OH 45459 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2003-02-10 |
| Summary: | summary |