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510(k) K931457

NDM SILVON ECG ELECTRODES by Ndm Acquisition Corp. — Product Code DRX

K931457 is an FDA 510(k) premarket notification submitted by Ndm Acquisition Corp. for the device "NDM SILVON ECG ELECTRODES". The FDA issued a decision of Substantially Equivalent on November 23, 1993. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Ndm Acquisition Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1993
Date Received
March 23, 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 Ndm Acquisition Corp.

  • K943287 — ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP (December 27, 1994)
  • K934601 — NDM HYDROGAUZE WOUND DRESSING (February 15, 1994)
  • K914207 — CLEARSITE(R) STERILE WOUND CARE DRESSING (October 23, 1991)

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