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510(k) K930312

3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE by 3M Health Care, Ltd. — Product Code DRX

K930312 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE". The FDA issued a decision of Substantially Equivalent on September 1, 1993. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1993
Date Received
January 22, 1993
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 3M Health Care, Ltd.

  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K926364 — ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (March 31, 1995)
  • K941534 — MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM (March 6, 1995)
  • K941748 — STERI-VAC GAS STERILIZER MODEL 8XL (December 2, 1994)
  • K930681 — 3M PREVENTION FABRIC SURGICAL GOWN #78XX (February 10, 1994)
  • K932307 — 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (January 7, 1994)
  • K932422 — 3M TEGADERM HP TRANSPARENT DRESSING (December 27, 1993)
  • K932446 — INJECTION SITE (November 29, 1993)
  • K931968 — CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO (November 10, 1993)
  • K933006 — AVI INFUSION PUMPS, ADDITIONAL INTENDED USE (October 25, 1993)

Other clearances for product code DRX

  • K171244 — Physiotrace (August 23, 2017)
  • K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (July 24, 2014)
  • K123658 — BIOMODULE 3-M1 (April 24, 2013)
  • 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)

FDA data resources