The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Er-1000 Catherization C-arm Systems.
| Device ID | K914348 |
| 510k Number | K914348 |
| Device Name: | ER-1000 CATHERIZATION C-ARM SYSTEMS |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Contact | De Mint |
| Correspondent | De Mint SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia, CA 90248 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-27 |
| Decision Date | 1991-11-01 |