510(k) K113053
K113053 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "BIPAP A 30 VENTILATORY SUPPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 2012. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2012
- Date Received
- October 13, 2011
- Clearance Type
- Abbreviated
- 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