Companion
FDA 510(k) clearance DEN140033 · decided 2017-02-16
Clearance details
- K-number
- DEN140033
- Device name
- Companion
- Applicant
- Lgch, Inc.
- Decision
- Unknown
- Date received
- 2014-11-10
- Decision date
- 2017-02-16
- Days to decision
- 829 days
- Clearance type
- Direct
- Product code
- POS
- Device class
- 2
- Regulation number
- 882.1580
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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| Embrace (K181861) | Empatica S.r.l. | 2018-12-20 |
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Recalls involving this device
No recalls on record reference this clearance.