The following data is part of a premarket notification filed by Invia with the FDA for Corridor4dm.
Device ID | K080575 |
510k Number | K080575 |
Device Name: | CORRIDOR4DM |
Classification | System, Tomography, Computed, Emission |
Applicant | INVIA 200 Homer Avenue Ashland, MA 01721 |
Contact | F. David Rothkopf |
Correspondent | F. David Rothkopf INVIA 200 Homer Avenue Ashland, MA 01721 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-02-29 |
Decision Date | 2008-05-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CORRIDOR4DM 77506442 3569741 Live/Registered |
INVIA LLC 2008-06-24 |