ZYNO MEDICAL ADMINISTRATION SET
FDA 510(k) clearance K132841 · decided 2014-01-23
Clearance details
- K-number
- K132841
- Device name
- ZYNO MEDICAL ADMINISTRATION SET
- Applicant
- Zyno Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-09-10
- Decision date
- 2014-01-23
- Days to decision
- 135 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Natick, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or G recall (Z-2893-2016) | Zyno Medical LLC | 2016-09-27 |
| Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or G recall (Z-2894-2016) | Zyno Medical LLC | 2016-09-27 |
| Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or G recall (Z-2895-2016) | Zyno Medical LLC | 2016-09-27 |
| Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gr recall (Z-2896-2016) | Zyno Medical LLC | 2016-09-27 |