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510(k) K932299

ELECTRO-MESH by Prizm Medical, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1994
Date Received
May 11, 1993
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 Prizm Medical, Inc.

  • K133502 — 5000Z FIREFLY SYSTEM (December 3, 2014)
  • K033122 — 5000Z SYSTEM (OTC) (August 25, 2004)
  • K032239 — THERA-CREAM, MODEL TCT004 (July 30, 2004)
  • K024181 — PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM (June 26, 2003)
  • K012974 — PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 (July 23, 2002)
  • K951727 — Z-WATCH SYSTEM (November 21, 1995)
  • K944487 — ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES (February 21, 1995)

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  • K250841 — Electrotherapy Electrodes (August 13, 2025)
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  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
  • K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (November 25, 2024)