510(k) K890921
K890921 is an FDA 510(k) premarket notification submitted by Siemens Life Support Systems for the device "DATA EXCHANGE SYSTEM, MODEL 24". The FDA issued a decision of Substantially Equivalent on June 8, 1989. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Siemens Life Support Systems has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1989
- Date Received
- February 24, 1989
- 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