510(k) K113640
K113640 is an FDA 510(k) premarket notification submitted by Resmed Germany, Inc. for the device "STELLAR 150". The FDA issued a decision of Substantially Equivalent on April 5, 2012. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Resmed Germany, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2012
- Date Received
- December 9, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sv70 Ventilator
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type