The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Cath Multidirect Bi-plane Radio Syst Mh-51a/mh-31a.
| Device ID | K903372 |
| 510k Number | K903372 |
| Device Name: | CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A |
| Classification | System, X-ray, Angiographic |
| 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 | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-26 |
| Decision Date | 1990-11-29 |