The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Clearvision.
Device ID | K112380 |
510k Number | K112380 |
Device Name: | CLEARVISION |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | MIDMARK CORP. 675 HEATHROW DRIVE Lincolnshire, IL 60069 |
Contact | Lisa Bartakovics |
Correspondent | Lisa Bartakovics MIDMARK CORP. 675 HEATHROW DRIVE Lincolnshire, IL 60069 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-17 |
Decision Date | 2011-11-22 |
Summary: | summary |