510(k) K213098
K213098 is an FDA 510(k) premarket notification submitted by Origin Medical Devices for the device "Panther 5". The FDA issued a decision of Substantially Equivalent on July 20, 2023. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2023
- Date Received
- September 24, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type