The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Zonograph 6.
Device ID | K810307 |
510k Number | K810307 |
Device Name: | ZONOGRAPH 6 |
Classification | System, X-ray, Tomographic |
Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IZF |
CFR Regulation Number | 892.1740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-05 |
Decision Date | 1981-03-11 |