510(k) K121661
K121661 is an FDA 510(k) premarket notification submitted by Assist Fill, LLC for the device "EZ-ASSIST-FILL". The FDA issued a decision of Substantially Equivalent on December 27, 2012. The device falls under product code PCM (Portable Liquid Oxygen Unit Stand), a Class I device regulated under 21 CFR 890.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2012
- Date Received
- June 5, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Portable Liquid Oxygen Unit Stand
- Device Class
- Class I
- Regulation Number
- 890.5050
- Review Panel
- AN
- Submission Type
To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.