510(k) K113633
K113633 is an FDA 510(k) premarket notification submitted by Mckesson Technologies, Inc. for the device "MCKESSON ANESTHESIA CARE". The FDA issued a decision of Substantially Equivalent on April 20, 2012. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2012
- Date Received
- December 8, 2011
- Clearance Type
- Traditional
- 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