510(k) K231064
K231064 is an FDA 510(k) premarket notification submitted by Smd Manufacturing, LLC for the device "ReddyPort Elbow". The FDA issued a decision of Substantially Equivalent on July 13, 2023. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Smd Manufacturing, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2023
- Date Received
- April 14, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Non-Life-Supporting
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type