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510(k) K920429

MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM by Hewlett-Packard Co. — Product Code MLD

K920429 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 20, 1993. The device falls under product code MLD (Monitor, St Segment With Alarm), a Class II device regulated under 21 CFR 870.1025. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1993
Date Received
February 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, St Segment With Alarm
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Hewlett-Packard Co.

  • K992543 — HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE (May 18, 2000)
  • K993383 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M300 (February 3, 2000)
  • K992273 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M304 (January 28, 2000)
  • K993587 — HP M2376A DEVICE LINK SYSTEM (January 20, 2000)
  • K993169 — MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A (December 20, 1999)
  • K992595 — HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUR (December 8, 1999)
  • K992977 — HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A (December 1, 1999)
  • K993516 — HP M2600A VIRIDIA TELEMETRY SYSTEM (November 8, 1999)
  • K992674 — HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A (November 8, 1999)
  • K993171 — HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A (October 21, 1999)

Other clearances for product code MLD

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • K080461 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 (March 13, 2008)
  • K022740 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAR (November 14, 2002)
  • K012837 — MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (September 14, 2001)
  • K002105 — SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS (December 5, 2000)
  • K992323 — DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (November 1, 1999)
  • K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (November 25, 1998)
  • K974492 — SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYS (February 26, 1998)
  • K972121 — ACUITY CENTRAL STATION (November 7, 1997)
  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)

FDA data resources