510(k) K853178
K853178 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 28, 1986. The device falls under product code HCB (Device, Aversive Conditioning), a Class II device regulated under 21 CFR 882.5235. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1986
- Date Received
- July 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Aversive Conditioning
- Device Class
- Class II
- Regulation Number
- 882.5235
- Review Panel
- NE
- Submission Type