The following data is part of a premarket notification filed by Imation Corp. with the FDA for Imation Trimatic Digital System.
Device ID | K984252 |
510k Number | K984252 |
Device Name: | IMATION TRIMATIC DIGITAL SYSTEM |
Classification | Digitizer, Image, Radiological |
Applicant | IMATION CORP. 1 IMATION PLACE Oakdale, MN 55128 |
Contact | Stephen G Slavens |
Correspondent | Stephen G Slavens IMATION CORP. 1 IMATION PLACE Oakdale, MN 55128 |
Product Code | LMA |
CFR Regulation Number | 892.2030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-27 |
Decision Date | 1999-01-25 |
Summary: | summary |