S dispensing line
FDA 510(k) clearance K192770 · decided 2020-12-17
Clearance details
- K-number
- K192770
- Device name
- S dispensing line
- Applicant
- Aea Srl
- Decision
- Substantially Equivalent
- Date received
- 2019-09-30
- Decision date
- 2020-12-17
- Days to decision
- 444 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Angeli De Rosora, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.