The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Ge Oec Altitude.
| Device ID | K071717 |
| 510k Number | K071717 |
| Device Name: | GE OEC ALTITUDE |
| Classification | System, X-ray, Angiographic |
| Applicant | SHIMADZU CORP. 1,NISHINOKYO-KUWABARACHO, NAKAGYOKU Kyoto City, JP 604-8511 |
| Contact | Akira Shigeyasu |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-06-22 |
| Decision Date | 2007-07-05 |
| Summary: | summary |