Envision ultrasound pad and cover
FDA 510(k) clearance K190802 · decided 2019-05-24
Clearance details
- K-number
- K190802
- Device name
- Envision ultrasound pad and cover
- Applicant
- Civco Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2019-03-29
- Decision date
- 2019-05-24
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kalona, IA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.