510(k) K871158
K871158 is an FDA 510(k) premarket notification submitted by Human Technologies, Inc. for the device "SIBIS REMOTE ACTUATOR". The FDA issued a decision of Substantially Equivalent on May 29, 1987. The device falls under product code HCB (Device, Aversive Conditioning), a Class II device regulated under 21 CFR 882.5235. Human Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 1987
- Date Received
- March 24, 1987
- 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