510(k) K823194
K823194 is an FDA 510(k) premarket notification submitted by Spelson Research Laboratories, Inc. for the device "SKIN GALVANOMETER". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code HCJ (Device, Skin Potential Measurement), a Class II device regulated under 21 CFR 882.1560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1983
- Date Received
- October 26, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Skin Potential Measurement
- Device Class
- Class II
- Regulation Number
- 882.1560
- Review Panel
- NE
- Submission Type