CytonPro-5000
FDA 510(k) clearance K213524 · decided 2022-08-10
Clearance details
- K-number
- K213524
- Device name
- CytonPro-5000
- Applicant
- Cytonsys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-03
- Decision date
- 2022-08-10
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.