510(k) K072884
K072884 is an FDA 510(k) premarket notification submitted by Draeger Medical AG & Co. KG for the device "FABIUS MRI". The FDA issued a decision of Substantially Equivalent on July 30, 2008. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Draeger Medical AG & Co. KG has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2008
- Date Received
- October 9, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type