510(k) K192307
K192307 is an FDA 510(k) premarket notification submitted by Nihon Kohden Orangemed, Inc. for the device "Nihon Kohden NKV-550 Series Ventilator System". The FDA issued a decision of Substantially Equivalent on Jan 10, 2020. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Nihon Kohden Orangemed, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 10, 2020
- Date Received
- Aug 26, 2019
- 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
- 510(k)