The following data is part of a premarket notification filed by Mtre Advanced Technology Ltd. with the FDA for Criticool Pro.
| Device ID | K102112 |
| 510k Number | K102112 |
| Device Name: | CRITICOOL PRO |
| Classification | System, Thermal Regulating |
| Applicant | MTRE ADVANCED TECHNOLOGY LTD. 4 HA-YARDEN ST. (P.O.BOX 102 REHOVOT 76100) Yavne, IL 81228 |
| Contact | Ifat Oren |
| Correspondent | Ifat Oren MTRE ADVANCED TECHNOLOGY LTD. 4 HA-YARDEN ST. (P.O.BOX 102 REHOVOT 76100) Yavne, IL 81228 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-28 |
| Decision Date | 2010-11-18 |