510(k) K161472
K161472 is an FDA 510(k) premarket notification submitted by Essex Industries, Inc. for the device "Walk-O2-Bout". The FDA issued a decision of Substantially Equivalent on November 18, 2016. The device falls under product code ECX (Cylinder, Compressed Gas, And Valve), a Class I device regulated under 21 CFR 868.2700. Essex Industries, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2016
- Date Received
- May 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cylinder, Compressed Gas, And Valve
- Device Class
- Class I
- Regulation Number
- 868.2700
- Review Panel
- AN
- Submission Type