510(k) K083227
K083227 is an FDA 510(k) premarket notification submitted by Vida Diagnostics, Inc. for the device "VIDA PULMONARY WORKSTATION 2 (PW2)". The FDA issued a decision of Substantially Equivalent on Nov 18, 2008. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Vida Diagnostics, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2008
- Date Received
- Nov 3, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)