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510(k) K833113

REPORTING INTEGRATOR 3392A by Hewlett-Packard Co. — Product Code LDM

K833113 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "REPORTING INTEGRATOR 3392A". The FDA issued a decision of Substantially Equivalent on November 21, 1983. The device falls under product code LDM (Instrumentation, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1983
Date Received
September 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrumentation, High Pressure Liquid Chromatography
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
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 LDM

  • K960392 — CDM (July 8, 1996)
  • K961557 — ALLIANCE 2690 SEPARATIONS MODULE (July 5, 1996)
  • K942451 — BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM (November 10, 1994)
  • K922388 — WATERS(TM) LC MODULE I FOR CLINICAL USE (September 11, 1992)
  • K920136 — WATERS 717 AUTOSAMPLER (February 19, 1992)
  • K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (September 11, 1990)
  • K884886 — MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (February 2, 1989)
  • K872582 — HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (July 16, 1987)
  • K870949 — WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM (April 22, 1987)
  • K862178 — ISOPURE LC SYSTEM (July 14, 1986)

FDA data resources