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 |