510(k) K884879
K884879 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "CENTURION(TM) MIXER". The FDA issued a decision of Substantially Equivalent on February 9, 1989. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Matrix Medica, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1989
- Date Received
- November 21, 1988
- 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