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510(k) K011564

NEOLEAD by Neotech Products, Inc. — Product Code DRX

K011564 is an FDA 510(k) premarket notification submitted by Neotech Products, Inc. for the device "NEOLEAD". The FDA issued a decision of Substantially Equivalent on January 3, 2002. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Neotech Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2002
Date Received
May 21, 2001
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 Neotech Products, Inc.

  • K931727 — URINARY DRAINAGE BAG CADDY (July 23, 1993)
  • K921024 — URO-TOTE LEG BAG (September 2, 1992)
  • K890425 — NEOTECH MUCUS TRAP W/CATHETER (April 19, 1989)
  • K882203 — NEOTECH UNIVERSAL ADAPTER (June 17, 1988)
  • K880487 — NEOTECH MECONIUM ASPIRATOR (STERILE) (May 6, 1988)

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