Deltaven XiV Max, Deltaven XiV Max FF
FDA 510(k) clearance K171530 · decided 2017-12-21
Clearance details
- K-number
- K171530
- Device name
- Deltaven XiV Max, Deltaven XiV Max FF
- Applicant
- Delta Med Spa
- Decision
- Substantially Equivalent
- Date received
- 2017-05-25
- Decision date
- 2017-12-21
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Viadana, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.