510(k) K123006
K123006 is an FDA 510(k) premarket notification submitted by Nimbic Systems, Inc. for the device "AIR BARRIER SYSTEM (ABS)". The FDA issued a decision of Substantially Equivalent on Dec 20, 2013. The device falls under product code ORC (Air Filter Portable Apparatus), a Class II device regulated under 21 CFR 878.5070. Nimbic Systems, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2013
- Date Received
- Sep 27, 2012
- 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
- 510(k)
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.