Myocene
FDA 510(k) clearance DEN230051 · decided 2025-01-17
Clearance details
- K-number
- DEN230051
- Device name
- Myocene
- Applicant
- Myocene
- Decision
- Unknown
- Date received
- 2023-07-27
- Decision date
- 2025-01-17
- Days to decision
- 540 days
- Clearance type
- Direct
- Product code
- SDX
- Device class
- 2
- Regulation number
- 882.1871
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Liège, BE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Myocene
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.