The following data is part of a premarket notification filed by Mespere Lifesciences Inc. with the FDA for Central Venous Pressure System - Mespere Venus 1000.
| Device ID | K131085 |
| 510k Number | K131085 |
| Device Name: | CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 |
| Classification | Non-invasive Central Venous Manometer |
| Applicant | MESPERE LIFESCIENCES INC. 180 FROBISHER DR, UNIT 1C Waterloo, On, CA N2v 2a2 |
| Contact | Helen Tan |
| Correspondent | Helen Tan MESPERE LIFESCIENCES INC. 180 FROBISHER DR, UNIT 1C Waterloo, On, CA N2v 2a2 |
| Product Code | PFA |
| CFR Regulation Number | 870.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-18 |
| Decision Date | 2013-08-22 |
| Summary: | summary |