The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Multix U. Bucky Table X-ray Unit.
Device ID | K803130 |
510k Number | K803130 |
Device Name: | MULTIX U. BUCKY TABLE X-RAY UNIT |
Classification | System, X-ray, Stationary |
Applicant | SIEMENS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-12 |
Decision Date | 1981-01-28 |