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MADA MEDICAL PRODUCTS, INC.

MADA MEDICAL PRODUCTS, INC · Model 1701-A · UDI-DI 00815160021235

CAX

510(k) clearances

157

Adverse events (15 deaths)

Recalls

Facilities

Description

A device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

Recalls

Date	Firm	Reason
2008-08-26	Porter Instrument Co Inc	inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.