Ponto 4
FDA 510(k) clearance K190540 · decided 2019-05-02
Clearance details
- K-number
- K190540
- Device name
- Ponto 4
- Applicant
- Oticon Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2019-03-04
- Decision date
- 2019-05-02
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- LXB
- Device class
- 2
- Regulation number
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Askim, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.