510(k) K191394
K191394 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "ILLUMISITE Platform". The FDA issued a decision of Substantially Equivalent on Aug 7, 2019. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Covidien, LLC has 224 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 7, 2019
- Date Received
- May 24, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)