510(k) K993167
K993167 is an FDA 510(k) premarket notification submitted by Sechrist Industries, Inc. for the device "MILLENNIUM INFANT VENTILATOR". The FDA issued a decision of ST on November 10, 1999. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Sechrist Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- November 10, 1999
- Date Received
- September 22, 1999
- Clearance Type
- Special
- 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