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510(k) K813176

GEL ELECTRODE by Dyn-A-Med Products — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
November 12, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

Other clearances by Dyn-A-Med Products

  • K844121 — CLAMP, TUBING, LINE (December 17, 1984)
  • K811157 — BLADE, TONGUE (May 27, 1981)
  • K802764 — PLASTIC ADHESIVE BANDAGE (November 24, 1980)
  • K802139 — SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY (October 31, 1980)

Other clearances for product code DRX

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  • K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (July 22, 2010)
  • K101685 — IP-SET (July 1, 2010)
  • K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (June 11, 2010)
  • K093327 — INTCO TAB ELECTRODE (May 10, 2010)
  • K100315 — 12 LEAD GLOVE (April 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)