510(k) K912346
K912346 is an FDA 510(k) premarket notification submitted by Medikeeper, Inc. for the device "MEDIKEEPER". The FDA issued a decision of Substantially Equivalent on July 30, 1991. 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
- July 30, 1991
- Date Received
- May 28, 1991
- 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