510(k) K081670
K081670 is an FDA 510(k) premarket notification submitted by Cardinal Health 207, Inc. for the device "THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK". The FDA issued a decision of Substantially Equivalent on October 9, 2008. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Cardinal Health 207, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2008
- Date Received
- June 13, 2008
- 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