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510(k) K911989

GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. by Somnitec, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1991
Date Received
May 6, 1991
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 Somnitec, Inc.

  • K912817 — SOMNIMIC (R) (July 26, 1991)
  • K912234 — SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION (July 22, 1991)
  • K911990 — ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. (June 21, 1991)

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