MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE— 510(k) K940896

Name: FDA 510(k) clearance K940896
Creator: U.S. Food and Drug Administration
Published: 1994-08-11

Substantially Equivalent

Medex, Inc.

FDA 510(k) clearance K940896 for MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE, Substantially Equivalent on 1994-08-11. Applicant: Medex, Inc.. Device class: 2.

Clearance details

Applicant: Medex, Inc.
Product code: Code MAV
Device class: Class 2
Regulation: 21 CFR 870.1650
Advisory panel: Cardiovascular
Date received: 1994-02-24
Decision date: 1994-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilliard, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAV

view all

More clearances from Medex, Inc.

view all

K042432 — PHARMGUARD TOOLBOX, MODEL G60007822005-01-04
K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP2004-04-30
K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP2002-05-20
K000328 — MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP2000-05-09
K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP1999-04-06

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.