510(k) K061785
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 2006
- Date Received
- June 23, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Regulator, Pressure, Gas Cylinder
- Device Class
- Class I
- Regulation Number
- 868.2700
- Review Panel
- AN
- Submission Type