The following data is part of a premarket notification filed by Twin Star Medical with the FDA for Twin Star Compartment Pressure Monitoring And Fluid Collection Monitor (cms Monitor).
| Device ID | K060963 |
| 510k Number | K060963 |
| Device Name: | TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR) |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | TWIN STAR MEDICAL 1000 WESTGATE DRIVE, SUITE 117 St. Paul, MN 55114 |
| Contact | Chet Sievert |
| Correspondent | Chet Sievert TWIN STAR MEDICAL 1000 WESTGATE DRIVE, SUITE 117 St. Paul, MN 55114 |
| Product Code | LXC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2006-06-06 |
| Summary: | summary |