Calprest, EasyCal
FDA 510(k) clearance K191589 · decided 2019-07-10
Clearance details
- K-number
- K191589
- Device name
- Calprest, EasyCal
- Applicant
- Eurospital S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-14
- Decision date
- 2019-07-10
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- NXO
- Device class
- 2
- Regulation number
- 866.5180
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Trieste, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.