The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Sirognathograph.
Device ID | K843951 |
510k Number | K843951 |
Device Name: | SIROGNATHOGRAPH |
Classification | Device, Jaw Tracking, For Monitoring Jaw Positions |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Contact | Barbara Klier |
Correspondent | Barbara Klier SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Product Code | NFS |
CFR Regulation Number | 872.2060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-09 |
Decision Date | 1984-11-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SIROGNATHOGRAPH 73721297 1510846 Dead/Cancelled |
SIEMENS AKTIENGESELLSCHAFT 1988-04-08 |