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510(k) K853633

TENS CONDUCTIVE MEDIA PAD by Alternative Design Systems, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1985
Date Received
August 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Alternative Design Systems, Inc.

  • K874719 — STRATUM ESU (February 16, 1988)
  • K874697 — STRATUM D (December 15, 1987)
  • K854757 — 5000 SERIES ECG ELECTRODES (April 23, 1986)
  • K852515 — ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR (June 24, 1985)
  • K830778 — MONITORING KIT AMK-1 (October 14, 1983)

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