MODEL 114 TREONIC H150 HAEMOHEATER— 510(k) K790936

Name: FDA 510(k) clearance K790936
Creator: U.S. Food and Drug Administration
Published: 1979-09-04

Substantially Equivalent

Vickers America Medical Corp.

FDA 510(k) clearance K790936 for MODEL 114 TREONIC H150 HAEMOHEATER, Substantially Equivalent on 1979-09-04. Applicant: Vickers America Medical Corp.. Device class: 2.

Clearance details

Applicant: Vickers America Medical Corp.
Product code: Code KZL
Device class: Class 2
Regulation: 21 CFR 864.9205
Advisory panel: Hematology
Date received: 1979-05-18
Decision date: 1979-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZL

view all

K813489 — ROCKING/CIRCULATING CYTO-THERM II 35701982-03-04
K812311 — CIRCULATING CYTO-THERMS1981-09-16
K800699 — FLO TEM (FLUID WARNER)1980-05-08

More clearances from Vickers America Medical Corp.

view all

K840823 — TREONIC C301984-03-23
K831838 — LABORATORY DATA MGMT SYSTEM SDMS1984-01-24
K830748 — RESUSCITAIRE1983-06-22
K830936 — TREONIC IP51983-04-12
K813239 — OXYGENAIRE NURING INCUBATOR1982-01-28

Adverse events under product code KZL

product code KZL

Death: 3
Malfunction: 473
Total: 476

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.