Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
FDA 510(k) clearance K181870 · decided 2019-02-26
Clearance details
- K-number
- K181870
- Device name
- Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
- Applicant
- Wuhan W.E.O Science & Technology Development Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-07-12
- Decision date
- 2019-02-26
- Days to decision
- 229 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wuhun, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.