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510(k) K903437

DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER by Keller Medical Specialties Products, Inc. — Product Code DRO

K903437 is an FDA 510(k) premarket notification submitted by Keller Medical Specialties Products, Inc. for the device "DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER". The FDA issued a decision of Substantially Equivalent on November 16, 1990. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Keller Medical Specialties Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1990
Date Received
July 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

Other clearances by Keller Medical Specialties Products, Inc.

  • K990648 — KELLER VITAL SIGNS MONITOR, KMS 890+ (August 10, 1999)
  • K982331 — KELLER PULSE OXIMETER, MODEL 850+ (September 11, 1998)
  • K914576 — KELLER CARDIAC MONITOR MEDIL KMS870 (December 30, 1991)
  • K910262 — KELLER VITAL SIGNS MONITOR - KMS-890 (April 1, 1991)
  • K895987 — KELLER PULSE OXIMETER - KMS 850 (February 22, 1990)

Other clearances for product code DRO

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)
  • K951593 — LIFEPAK 11 (December 29, 1995)

FDA data resources