510(k) K061785
K061785 is an FDA 510(k) premarket notification submitted by Responsive Respiratory, Inc. for the device "CYL-FIL OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on September 7, 2006. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Responsive Respiratory, Inc. has at least 1 other 510(k) clearance on record.
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