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

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..

Clearance details

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

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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.