The following data is part of a premarket notification filed by Mtre Advanced Technology Ltd. with the FDA for Allon 2000.
| Device ID | K992386 |
| 510k Number | K992386 |
| Device Name: | ALLON 2000 |
| Classification | System, Thermal Regulating |
| Applicant | MTRE ADVANCED TECHNOLOGY LTD. 117 AHUZAH ST Raananna, IL 43373 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman MTRE ADVANCED TECHNOLOGY LTD. 117 AHUZAH ST Raananna, IL 43373 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-16 |
| Decision Date | 2000-03-07 |
| Summary: | summary |