The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Somatom 2.
Device ID | K790975 |
510k Number | K790975 |
Device Name: | SOMATOM 2 |
Classification | System, X-ray, Tomography, Computed |
Applicant | SIEMENS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-23 |
Decision Date | 1979-07-30 |