The following data is part of a premarket notification filed by Plum Medical Solutions Gmbh with the FDA for Med-tab.
Device ID | K173241 |
510k Number | K173241 |
Device Name: | MED-TAB |
Classification | System, Image Processing, Radiological |
Applicant | PLUM Medical Solutions GmbH Lange StraBe 16 Rostock, DE 18055 |
Contact | Arpad Bischof |
Correspondent | Carl Alletto OTech Inc. 8317 Belew Drive Mckinney, TX 75071 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-06 |
Decision Date | 2018-03-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MED-TAB 86860936 not registered Dead/Abandoned |
IMAGE Information Systems Ltd. 2015-12-29 |