SREE MRI Transport Incubator
FDA 510(k) clearance K161918 · decided 2017-03-03
Clearance details
- K-number
- K161918
- Device name
- SREE MRI Transport Incubator
- Applicant
- Advanced Imaging Research Dba Sree Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2016-07-13
- Decision date
- 2017-03-03
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- FPL
- Device class
- 2
- Regulation number
- 880.5410
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Advanced Imaging Research Dba Sree Medical Systems
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.