The following data is part of a premarket notification filed by Vectracor, Inc with the FDA for Vectraplex Cms.
| Device ID | K140852 |
| 510k Number | K140852 |
| Device Name: | VECTRAPLEX CMS |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | VECTRACOR, INC 785 TOTOWA ROAD SUITE, 100 Totowa, NJ 07512 |
| Contact | Brad S Schreck |
| Correspondent | Brad S Schreck VECTRACOR, INC 785 TOTOWA ROAD SUITE, 100 Totowa, NJ 07512 |
| Product Code | MSX |
| Subsequent Product Code | MHX |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2015-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857175006012 | K140852 | 000 |