510(k) K051222
K051222 is an FDA 510(k) premarket notification submitted by Penlon Limited for the device "AV-S ANAESTHESIA VENTILATOR". The FDA issued a decision of Substantially Equivalent on September 23, 2005. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Penlon Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2005
- Date Received
- May 12, 2005
- 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