510(k) K042419
K042419 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM". The FDA issued a decision of Substantially Equivalent on October 8, 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
- October 8, 2004
- Date Received
- September 7, 2004
- 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