BIOCUFF INFUSION BAG PRESSOR— 510(k) K832377

Name: FDA 510(k) clearance K832377
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

Bio-Medical Instruments , Ltd.

FDA 510(k) clearance K832377 for BIOCUFF INFUSION BAG PRESSOR, Substantially Equivalent on 1983-08-12. Applicant: Bio-Medical Instruments , Ltd.. Device class: 1.

Clearance details

Applicant: Bio-Medical Instruments , Ltd.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1983-07-19
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZD

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K974074 — INFUSION DYNAMICS POWER INFUSER1998-02-17
K973843 — MSI PRESSURE INFUSOR1997-10-29
K953290 — OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP1995-10-07
K951988 — PRESSURIZER1995-06-14
K942933 — PRESSURE INFUSION CUFF1994-08-25

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.