Home / 510(k) Clearances / K843815

510(k) K843815

EVOMATIC 8000/4000 by Dantec Electronics, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1985
Date Received
September 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Dantec Electronics, Inc.

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  • K884915 — DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER (October 4, 1989)
  • K881915 — DANTEC MAGNETIC STIMULATOR (October 17, 1988)
  • K874759 — 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE (April 14, 1988)
  • K874758 — DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE (April 14, 1988)
  • K874735 — DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE (January 22, 1988)
  • K870567 — EVOPORT 300 (October 6, 1987)
  • K872106 — DANTEC COUNTERPOINT (September 10, 1987)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)

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