510(k) K920121
K920121 is an FDA 510(k) premarket notification submitted by Sechrist for the device "SECHRIST IV-100B SAVI SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 1993. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Sechrist has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1993
- Date Received
- January 13, 1992
- 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