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510(k) K240884

Glide (91000-GL-X) by Infinite Biomedical Technologies, LLC — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2024
Date Received
April 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Infinite Biomedical Technologies, LLC

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  • K091963 — VIGILANT EEG MONITOR, VIGILANT 2.0 (November 6, 2009)
  • K072382 — MODEL I-2000 MONITOR (February 15, 2008)

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  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
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