510(k) K030624
K030624 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM". The FDA issued a decision of Substantially Equivalent on March 17, 2004. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2004
- Date Received
- February 27, 2003
- 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