510(k) K993826
K993826 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "NARKOMED 6000". The FDA issued a decision of Substantially Equivalent on March 23, 2000. The device falls under product code MLC (Monitor, St Segment), a Class II device regulated under 21 CFR 870.2340. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2000
- Date Received
- November 12, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, St Segment
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type