The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for B-care5 (b-care5 Sensor Module, Venous Sensor, Holder For Measuring Head).
| Device ID | K103168 |
| 510k Number | K103168 |
| Device Name: | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-27 |
| Decision Date | 2011-01-06 |
| Summary: | summary |