The following data is part of a premarket notification filed by Microwave Medical Systems, Inc. with the FDA for Xdcs-100.
| Device ID | K932083 |
| 510k Number | K932083 |
| Device Name: | XDCS-100 |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MICROWAVE MEDICAL SYSTEMS, INC. 9 GOLDSMITH ST. P.O. BOX 188 Littleton, MA 01460 -0188 |
| Contact | James G Cudmore |
| Correspondent | James G Cudmore MICROWAVE MEDICAL SYSTEMS, INC. 9 GOLDSMITH ST. P.O. BOX 188 Littleton, MA 01460 -0188 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-30 |
| Decision Date | 1993-12-16 |