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Alpha MX (20)/Ultra PC (30)

by Technical Medical Products, Inc.

510(k) K970163

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970163 Date10 Dec 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BSZ
Device Class
Class II
Regulation
21 CFR Part 868.5160
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Alpha MX (20)/Ultra PC (30) is a gas machine for analgesia, designed to deliver nitrous oxide/oxygen mixtures to patients. It functions as part of sedation systems and limits nitrous oxide concentration to a maximum of 70%.

The device is supplied for use in clinical settings by healthcare professionals. It is regulated under FDA 510(k) clearance and is intended for single-use applications.

Other devices from Technical Medical Products, Inc.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Alpha MX Ultra PC gas machine used for?

    The Alpha MX Ultra PC is a gas machine designed to deliver nitrous oxide and oxygen mixtures for analgesia. It functions as part of sedation systems and is intended for use in clinical settings by healthcare professionals.

  • What is the maximum nitrous oxide concentration this device can deliver?

    The device is designed to limit the concentration of nitrous oxide to a maximum of 70%.

  • Is the Alpha MX Ultra PC intended for single use?

    Yes, the device is intended for single-use applications.

  • What is the regulatory status of the Alpha MX Ultra PC?

    The device is regulated under FDA 510(k) clearance.