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510(k) K943449

NEUROLOGICAL DIAGNOSTIC DEVICES by Henley Intl. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1995
Date Received
July 18, 1994
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 Henley Intl.

  • K926279 — UPPER BODY EXERCISER (May 5, 1994)
  • K926278 — STAIR CLIMBER (May 5, 1994)
  • K926287 — EXERCISE BICYCLE (March 22, 1994)
  • K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER (March 18, 1994)
  • K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS (February 4, 1994)
  • K915864 — MONOTRODE CUTANEOUS ELECTRODE (July 21, 1993)
  • K922036 — SONOPULS 591 (June 29, 1993)
  • K926316 — TRUE-TRAC, STRATUS (March 24, 1993)
  • K920983 — SONOPULS 590 (March 9, 1993)
  • K922020 — ENDOMED 582 (September 22, 1992)

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