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510(k) K760313

KIT, PREP, INSPIRON IV by Inspiron Corp. — Product Code KZD

K760313 is an FDA 510(k) premarket notification submitted by Inspiron Corp. for the device "KIT, PREP, INSPIRON IV". The FDA issued a decision of Substantially Equivalent on August 4, 1976. The device falls under product code KZD (Infusor, Pressure, For I.V. Bags), a Class I device regulated under 21 CFR 880.5420. Inspiron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1976
Date Received
July 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infusor, Pressure, For I.V. Bags
Device Class
Class I
Regulation Number
880.5420
Review Panel
HO
Submission Type

Other clearances by Inspiron Corp.

  • K860838 — INSPIRON DOUBLE SWIVEL TRACH ADAPTER (April 9, 1986)
  • K850346 — OXYGEN CONCENTRATOR (February 4, 1985)
  • K843932 — VAPOR-PHASE HUMIDIFIER SYS-ADVANCED (October 18, 1984)
  • K840935 — MANUAL RESUSCITATION SYSTEM (April 5, 1984)
  • K841158 — NEBULO 28 NEBULIZER KIT (March 30, 1984)
  • K840418 — INSPIRATORY/EXPIRATORY MUSCLE EXERCIS (February 17, 1984)
  • K834290 — INSPIRON LIQUID OXYGEN SYSTEM (February 4, 1984)
  • K772068 — MANIFOLD & NEBULIZER, UNIVERSAL (November 15, 1977)
  • K772071 — MANIFOLD & NEBU. FOR SINGLE LINE MACH. (November 15, 1977)
  • K772070 — VENTILATOR SETUP, VOLUME (November 15, 1977)

Other clearances for product code KZD

  • K974074 — INFUSION DYNAMICS POWER INFUSER (February 17, 1998)
  • K973843 — MSI PRESSURE INFUSOR (October 29, 1997)
  • K953290 — OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP (October 7, 1995)
  • K951988 — PRESSURIZER (June 14, 1995)
  • K942933 — PRESSURE INFUSION CUFF (August 25, 1994)
  • K930012 — KAWASUMI LABORATORIES K-CUFF (December 14, 1993)
  • K921168 — ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (April 21, 1993)
  • K913751 — PRESSURE INFUSER (January 9, 1992)
  • K910926 — TECNADYNE SURGI-SQUEEZE INFUSION PUMP (August 2, 1991)
  • K911216 — INFUSABLE (July 22, 1991)

FDA data resources