Z-800 INFUSION SYSTEM
FDA 510(k) clearance K130690 · decided 2013-06-12
Clearance details
- K-number
- K130690
- Device name
- Z-800 INFUSION SYSTEM
- Applicant
- Zyno Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-03-14
- Decision date
- 2013-06-12
- Days to decision
- 90 days
- Clearance type
- Special
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Natick, MA, US
- Third-party review
- No
- Expedited review
- No
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