The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Bransist Safire.
| Device ID | K062360 |
| 510k Number | K062360 |
| Device Name: | BRANSIST SAFIRE |
| Classification | System, X-ray, Angiographic |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Randal Walker |
| Correspondent | Randal Walker SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-14 |
| Decision Date | 2006-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217010479 | K062360 | 000 |