510(k) K081842
K081842 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "ENGSTROM CARESTATION, ENGSTROM PRO". The FDA issued a decision of Substantially Equivalent on October 3, 2008. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Datex-Ohmeda, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2008
- Date Received
- June 30, 2008
- 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