The following data is part of a premarket notification filed by Hermes Medical Solutions Ab with the FDA for Hybrid3d.
Device ID | K163394 |
510k Number | K163394 |
Device Name: | Hybrid3D |
Classification | System, Tomography, Computed, Emission |
Applicant | Hermes Medical Solutions AB Skeppsbron 44 Stockholm, SE 11130 |
Contact | Joakim Arwidson |
Correspondent | Joakim Arwidson Hermes Medical Solutions AB Skeppsbron 44 Stockholm, SE 11130 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-05 |
Decision Date | 2017-05-22 |
Summary: | summary |