Slow Wave DS8
FDA 510(k) clearance K191320 · decided 2020-10-02
Clearance details
- K-number
- K191320
- Device name
- Slow Wave DS8
- Applicant
- Slow Wave, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-15
- Decision date
- 2020-10-02
- Days to decision
- 506 days
- Clearance type
- Traditional
- Product code
- LQZ
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Spicewood, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.