SHARPSCAN
FDA 510(k) clearance K123807 · decided 2013-07-23
Clearance details
- K-number
- K123807
- Device name
- SHARPSCAN
- Applicant
- Medical Engineering Development Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-11
- Decision date
- 2013-07-23
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Northglenn, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Engineering Development Solutions
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.