KIT, PREP, INSPIRON IV— 510(k) K760313

Name: FDA 510(k) clearance K760313
Creator: U.S. Food and Drug Administration
Published: 1976-08-04

Substantially Equivalent

Inspiron Corp.

FDA 510(k) clearance K760313 for KIT, PREP, INSPIRON IV, Substantially Equivalent on 1976-08-04. Applicant: Inspiron Corp.. Device class: 1.

Clearance details

Applicant: Inspiron Corp.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1976-07-26
Decision date: 1976-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K951988 — PRESSURIZER1995-06-14
K942933 — PRESSURE INFUSION CUFF1994-08-25

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K860838 — INSPIRON DOUBLE SWIVEL TRACH ADAPTER1986-04-09
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K843932 — VAPOR-PHASE HUMIDIFIER SYS-ADVANCED1984-10-18
K840935 — MANUAL RESUSCITATION SYSTEM1984-04-05
K841158 — NEBULO 28 NEBULIZER KIT1984-03-30

Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.