B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)
FDA 510(k) K103168 · Sorin Group Deutschland GmbH
510(k) numberK103168
Submission
- Device name
- B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)
- Applicant
- Sorin Group Deutschland GmbH
North Attleboro, MA, US - Received
- October 27, 2010
- Decision date
- January 6, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
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Questions and answers
When was B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head) cleared by the FDA?
B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head) (K103168) received a 510(k) decision of Substantially Equivalent on January 6, 2011, 71 days after the submission was received.
What is the product code of K103168?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.