The following data is part of a premarket notification filed by Median Technologies with the FDA for Lms-lung/track.
Device ID | K070868 |
510k Number | K070868 |
Device Name: | LMS-LUNG/TRACK |
Classification | System, Image Processing, Radiological |
Applicant | MEDIAN TECHNOLOGIES 11 MYSTIC AVE. Winchester, MA 01890 -2920 |
Contact | Chas Burr |
Correspondent | Chas Burr MEDIAN TECHNOLOGIES 11 MYSTIC AVE. Winchester, MA 01890 -2920 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-29 |
Decision Date | 2007-05-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03760263520017 | K070868 | 000 |