nextaro Transfer System, nextaro va
FDA 510(k) clearance K183187 · decided 2019-03-15
Clearance details
- K-number
- K183187
- Device name
- nextaro Transfer System, nextaro va
- Applicant
- Sfm Medical Devices GmbH
- Decision
- Substantially Equivalent
- Date received
- 2018-11-19
- Decision date
- 2019-03-15
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Waechtersbach, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.