510(k) K101850
K101850 is an FDA 510(k) premarket notification submitted by Spacelabs Healthcare, Ltd. for the device "SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION". The FDA issued a decision of Substantially Equivalent on March 2, 2011. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Spacelabs Healthcare, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2011
- Date Received
- July 1, 2010
- 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