Ventway Sparrow
FDA 510(k) clearance K202970 · decided 2021-01-29
Clearance details
- K-number
- K202970
- Device name
- Ventway Sparrow
- Applicant
- Inovytech Medical Solutions , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-30
- Decision date
- 2021-01-29
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hod Hasharon Tel-Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.