The following data is part of a premarket notification filed by Pie Medical with the FDA for Imt.lab.
Device ID | K043360 |
510k Number | K043360 |
Device Name: | IMT.LAB |
Classification | System, Image Processing, Radiological |
Applicant | PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
Contact | Carri Graham |
Correspondent | Carri Graham PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-07 |
Decision Date | 2005-01-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMT.LAB 78678122 3232531 Dead/Cancelled |
Biosound Esaote, Inc. 2005-07-26 |