510(k) K092801
K092801 is an FDA 510(k) premarket notification submitted by Nimbic Systems, LLC for the device "ABS BLOWER, ABS NOZZLE, MODEL 1001". The FDA issued a decision of Substantially Equivalent on May 20, 2011. The device falls under product code ORC (Air Filter Portable Apparatus), a Class II device regulated under 21 CFR 878.5070. Nimbic Systems, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2011
- Date Received
- September 11, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Air Filter Portable Apparatus
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- HO
- Submission Type
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.