The following data is part of a premarket notification filed by Intelomed, Inc with the FDA for Cvinsight.
| Device ID | K120052 |
| 510k Number | K120052 |
| Device Name: | CVINSIGHT |
| Classification | Oximeter |
| Applicant | INTELOMED, INC 4284 LAMPL LN Allison Park, PA 15101 |
| Contact | Jan Berkow |
| Correspondent | Jan Berkow INTELOMED, INC 4284 LAMPL LN Allison Park, PA 15101 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-06 |
| Decision Date | 2012-09-04 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CVINSIGHT 85763643 4863505 Live/Registered |
Intelomed, Inc. 2012-10-25 |