The following data is part of a premarket notification filed by Intelligent Medical Devices, Inc with the FDA for Imdx Vanr For Abbott M2000.
| Device ID | K123753 |
| 510k Number | K123753 |
| Device Name: | IMDX VANR FOR ABBOTT M2000 |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
| Applicant | INTELLIGENT MEDICAL DEVICES, INC 180 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White INTELLIGENT MEDICAL DEVICES, INC 180 CABOT ST. Beverly, MA 01915 |
| Product Code | NIJ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-06 |
| Decision Date | 2013-07-17 |
| Summary: | summary |