BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
FDA 510(k) clearance K120823 · decided 2012-06-15
Clearance details
- K-number
- K120823
- Device name
- BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
- Applicant
- Fresenius Medical Care North America, Design Cente
- Decision
- Substantially Equivalent
- Date received
- 2012-03-19
- Decision date
- 2012-06-15
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FJK
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.