7400 Ultrasound Systems
FDA 510(k) clearance K190447 · decided 2019-04-01
Clearance details
- K-number
- K190447
- Device name
- 7400 Ultrasound Systems
- Applicant
- Navigant Consulting - on Behalf of Esaote S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-25
- Decision date
- 2019-04-01
- Days to decision
- 35 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.