510(k) K042276
K042276 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "D-VAPOR". The FDA issued a decision of Substantially Equivalent on September 23, 2004. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2004
- Date Received
- August 23, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vaporizer, Anesthesia, Non-Heated
- Device Class
- Class II
- Regulation Number
- 868.5880
- Review Panel
- AN
- Submission Type