The following data is part of a premarket notification filed by Medx, Inc. with the FDA for Medx Intecam Interface.
Device ID | K993893 |
510k Number | K993893 |
Device Name: | MEDX INTECAM INTERFACE |
Classification | System, Tomography, Computed, Emission |
Applicant | MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
Contact | Floyd Rowan |
Correspondent | Floyd Rowan MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-16 |
Decision Date | 2000-02-10 |
Summary: | summary |