The following data is part of a premarket notification filed by Steinbeis-transferzentrum Medizinische Informatik with the FDA for Chili Video, Chili Videopro.
Device ID | K000411 |
510k Number | K000411 |
Device Name: | CHILI VIDEO, CHILI VIDEOPRO |
Classification | Digitizer, Image, Radiological |
Applicant | STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK 24 EASTMAN AVE. C5 Bedford, NH 03110 |
Contact | Jim Doyle |
Correspondent | Jim Doyle STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK 24 EASTMAN AVE. C5 Bedford, NH 03110 |
Product Code | LMA |
CFR Regulation Number | 892.2030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-08 |
Decision Date | 2000-04-14 |