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510(k) K844632

INFANT LIMB ELECTRODE by Sentry Medical Products, Inc. — Product Code DRX

K844632 is an FDA 510(k) premarket notification submitted by Sentry Medical Products, Inc. for the device "INFANT LIMB ELECTRODE". The FDA issued a decision of Substantially Equivalent on January 14, 1985. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Sentry Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1985
Date Received
November 27, 1984
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 Sentry Medical Products, Inc.

  • K962122 — SENTRY RADIOTRANSLUCENT ECG ELECTRODES (July 24, 1996)
  • K955636 — SENTRY DISPOSABLE DISPERSIVE ELECTRODE (March 27, 1996)
  • K942827 — SENTRY INSERTION TRAY (November 2, 1994)
  • K934000 — SENTRY AQUEOUS GEL ECG ELECTRODES (August 30, 1994)
  • K935098 — BABY BOARD (February 15, 1994)
  • K933603 — LEADWIRE (January 18, 1994)
  • K932704 — PATIENT CABLE (December 27, 1993)
  • K881670 — ACCUTEMP PLUS (November 22, 1988)
  • K881343 — DURADERM BUTTERFLY (May 4, 1988)
  • K851522 — DIAGNOSTIC ECG DISPOSABLE ELECTRODE (October 24, 1985)

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