Neoasis
FDA 510(k) clearance DEN220048 · decided 2023-06-16
Clearance details
- K-number
- DEN220048
- Device name
- Neoasis
- Applicant
- Invictus Medical, Inc.
- Decision
- Unknown
- Date received
- 2022-07-25
- Decision date
- 2023-06-16
- Days to decision
- 326 days
- Clearance type
- Direct
- Product code
- QWX
- Device class
- 2
- Regulation number
- 880.5405
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.