510(k) K131790
K131790 is an FDA 510(k) premarket notification submitted by Oricare, Inc. for the device "A9800 ANESTHESIA WORKSTATION". The FDA issued a decision of Substantially Equivalent on May 9, 2014. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Oricare, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2014
- Date Received
- June 18, 2013
- 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