510(k) K122445
K122445 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda for the device "AESPIRE 7900, AESPIRE VIEW". The FDA issued a decision of Substantially Equivalent on October 12, 2012. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Datex-Ohmeda has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2012
- Date Received
- August 10, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type