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The Digital MXR-D Flowmeter is intended for use in nitrous oxide/oxygen sedation systems for the delivery of a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.

The proposed Digital MXR-D Flowmeter is a modification of the MXR 2000 Flowmeter that was cleared for marketing in the U.S. as K923781. The major modification to the MXR 2000 Flowmeter to produce the proposed Digital MXR-D Flowmeter is the addition of an electronically controlled digital display to the control panel of the cabinet mount version. The electronics incorporated in the Digital MXR-D Flowmeter function as follows: - Turn flow and clectronics on/off and display start-up information . - Display nitrous oxide (N2O) percentage and total flow . - . Display information and instructions (i.e. fault conditions and error codes) - . Provide an audible signal for certain fault conditions.

For control of vacuum flow in a gas scavenging apparatus, used as an accessory in Porter Instrument Company's Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines (flowmeters). The intended use of the AVS accessory is to control the vacuum flow in a gas scavenging apparatus. The intended use of the modified device, as described in our labeling, has not changed as a result of the modifications.

The automatic interlock switch (AVS) is a device intended to assure that analgesic gases cannot be turned on unless an activated scavenging system is present.