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510(k) K911990

ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. by Somnitec, Inc. — Product Code DRX

K911990 is an FDA 510(k) premarket notification submitted by Somnitec, Inc. for the device "ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.". The FDA issued a decision of Substantially Equivalent on June 21, 1991. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Somnitec, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1991
Date Received
May 6, 1991
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 Somnitec, Inc.

  • K911989 — GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. (July 30, 1991)
  • K912817 — SOMNIMIC (R) (July 26, 1991)
  • K912234 — SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION (July 22, 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