The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Sircam 106.
Device ID | K792394 |
510k Number | K792394 |
Device Name: | SIRCAM 106 |
Classification | Camera, X-ray, Fluorographic, Cine Or Spot |
Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IZJ |
CFR Regulation Number | 892.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-26 |
Decision Date | 1979-12-20 |