510(k) K112914
K112914 is an FDA 510(k) premarket notification submitted by Resmed, Ltd. for the device "VPAP TX". The FDA issued a decision of Substantially Equivalent on December 29, 2011. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Resmed, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2011
- Date Received
- October 3, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Non-Life-Supporting
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type