visor2 system
FDA 510(k) clearance K210109 · decided 2022-04-08
Clearance details
- K-number
- K210109
- Device name
- visor2 system
- Applicant
- Eemagine Medical Imaging Solutions GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-01-19
- Decision date
- 2022-04-08
- Days to decision
- 444 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Berlin, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Eemagine Medical Imaging Solutions GmbH
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.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.