The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Koordinant Angiographic And Operating Room Model X-ray Table Family.
Device ID | K993947 |
510k Number | K993947 |
Device Name: | KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY |
Classification | System, X-ray, Angiographic |
Applicant | SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
Contact | Alicia Juergensen |
Correspondent | Alicia Juergensen SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-22 |
Decision Date | 1999-12-21 |
Summary: | summary |