The following data is part of a premarket notification filed by Hicat Gmbh with the FDA for Hicat Air.
Device ID | K152661 |
510k Number | K152661 |
Device Name: | HICAT Air |
Classification | System, Image Processing, Radiological |
Applicant | HICAT GmbH Brunnenallee 6 Bonn, DE 53177 |
Contact | Frederik Kunze |
Correspondent | Frederik Kunze HICAT GmbH Brunnenallee 6 Bonn, DE 53177 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-17 |
Decision Date | 2015-11-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B06965436510 | K152661 | 000 |
D776AIRV200 | K152661 | 000 |
D776AIRV20400 | K152661 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HICAT AIR 79144862 4693807 Live/Registered |
hiCAT GmbH 2013-11-28 |