The following data is part of a premarket notification filed by Mespere Lifesciences Inc. with the FDA for Vo200 – Neuros Cerebral Oximetry System.
| Device ID | K182242 |
| 510k Number | K182242 |
| Device Name: | VO200 – NeurOs Cerebral Oximetry System |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Mespere LifeSciences Inc. 180 Frobisher Drive, Suite 1C Waterloo, CA N2v 2a2 |
| Contact | Rebecca S. Li |
| Correspondent | Rebecca S. Li Mespere LifeSciences Inc. 180 Frobisher Drive, Suite 1C Waterloo, CA N2v 2a2 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-20 |
| Decision Date | 2018-12-26 |
| Summary: | summary |