The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Bio Z Cardio Profile Hemodynamic Monitor.
| Device ID | K110645 |
| 510k Number | K110645 |
| Device Name: | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR |
| Classification | Plethysmograph, Impedance |
| Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
| Contact | Jessica R Stenberg |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-06-03 |
| Summary: | summary |