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 |