510(k) K051666
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2005
- Date Received
- June 22, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Vaporizer, Anesthesia, Non-Heated
- Device Class
- Class II
- Regulation Number
- 868.5880
- Review Panel
- AN
- Submission Type