The following data is part of a premarket notification filed by Isys Medizintechnik Gmbh with the FDA for Isys 1 (u.s),accessory, Non-sterile.
| Device ID | K131433 |
| 510k Number | K131433 |
| Device Name: | ISYS 1 (U.S),ACCESSORY, NON-STERILE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ISYS MEDIZINTECHNIK GMBH 56 WESTCOTT ROAD Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky ISYS MEDIZINTECHNIK GMBH 56 WESTCOTT ROAD Stamford, CT 06902 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-17 |
| Decision Date | 2014-03-11 |
| Summary: | summary |