ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
FDA 510(k) clearance K100705 · decided 2010-07-08
Clearance details
- K-number
- K100705
- Device name
- ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
- Applicant
- Zyno Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-03-12
- Decision date
- 2010-07-08
- Days to decision
- 118 days
- Clearance type
- Abbreviated
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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