510(k) K113743
K113743 is an FDA 510(k) premarket notification submitted by Event Medical, Inc. for the device "EVOLUTION 3E VENTILATOR". The FDA issued a decision of Substantially Equivalent on December 18, 2012. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Event Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2012
- Date Received
- December 20, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type