Hidroxa SE30
FDA 510(k) clearance K241267 · decided 2024-10-17
Clearance details
- K-number
- K241267
- Device name
- Hidroxa SE30
- Applicant
- Hidroxa Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2024-05-06
- Decision date
- 2024-10-17
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- EGJ
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Partille, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.