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510(k) K801846

ELECTROCARDIOGRAPH ELECTRODE by Phoenix Glove Co. — Product Code DRX

K801846 is an FDA 510(k) premarket notification submitted by Phoenix Glove Co. for the device "ELECTROCARDIOGRAPH ELECTRODE". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Phoenix Glove Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1980
Date Received
August 4, 1980
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 Phoenix Glove Co.

  • K830660 — STERILE SURGICAL DRAPES (March 17, 1983)
  • K821044 — PATIENT PREP KITS/TRAYS-STERILE (June 23, 1982)
  • K821666 — STERILE SURGICAL DRAPES (June 21, 1982)
  • K821043 — STERILE PATIENT EXAM. GLOVES (May 21, 1982)
  • K781820 — GLOVES, VINYL EXAMINATION (December 7, 1978)

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