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510(k) K832067

SHARE INT'L TDM by Share Int'L — Product Code HCJ

K832067 is an FDA 510(k) premarket notification submitted by Share Int'L for the device "SHARE INT'L TDM". The FDA issued a decision of Substantially Equivalent on October 27, 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
October 27, 1983
Date Received
June 27, 1983
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

Other clearances for product code HCJ

  • K823194 — SKIN GALVANOMETER (January 21, 1983)

FDA data resources