510(k) K871564
K871564 is an FDA 510(k) premarket notification submitted by Anestech, Inc. for the device "ANESTHASSIST". The FDA issued a decision of Substantially Equivalent on May 18, 1987. The device falls under product code BRY (Cabinet, Table And Tray, Anesthesia), a Class I device regulated under 21 CFR 868.6100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1987
- Date Received
- April 22, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, Table And Tray, Anesthesia
- Device Class
- Class I
- Regulation Number
- 868.6100
- Review Panel
- AN
- Submission Type