Compex HD
FDA 510(k) clearance K182017 · decided 2019-04-29
Clearance details
- K-number
- K182017
- Device name
- Compex HD
- Applicant
- Addent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-07-27
- Decision date
- 2019-04-29
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- QGO
- Device class
- 1
- Regulation number
- 872.6100
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Danbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.