HEMODIALYSIS TUBING SETS— 510(k) K001971
Substantially EquivalentOfi Biomedica S.P.A.
FDA 510(k) clearance K001971 for HEMODIALYSIS TUBING SETS, Substantially Equivalent on 2001-05-24. Applicant: Ofi Biomedica S.P.A.. Device class: 2.
Clearance details
- Applicant
- Ofi Biomedica S.P.A.
- Product code
- Code FIB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code FIB
view all- K240164 — NovaLine SP-C35 Transducer Protector (956007)
- K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
- K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
- K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
- K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
Data sourced from openFDA. This site is unofficial and independent of the FDA.