The following data is part of a premarket notification filed by Mespere Lifesciences Inc. with the FDA for Central Venous Pressure System.
| Device ID | K151776 |
| 510k Number | K151776 |
| Device Name: | Central Venous Pressure System |
| Classification | Non-invasive Central Venous Manometer |
| Applicant | Mespere LifeSciences Inc. 180 Frobisher Dr, Unit 1C Waterloo, On, CA N2v2a2 |
| Contact | Helen Tan |
| Correspondent | Helen Tan Mespere LifeSciences Inc. 180 Frobisher Dr, Unit 1C Waterloo, On, CA N2v2a2 |
| Product Code | PFA |
| CFR Regulation Number | 870.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-01 |
| Decision Date | 2015-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M9831109000011 | K151776 | 000 |
| M9831102000011 | K151776 | 000 |
| M9831104000021 | K151776 | 000 |
| M9831104000031 | K151776 | 000 |
| M9831105000061 | K151776 | 000 |
| M9831106000021 | K151776 | 000 |
| M9831107000031 | K151776 | 000 |
| M9831108000021 | K151776 | 000 |
| M9831108000031 | K151776 | 000 |
| M9831101000041 | K151776 | 000 |