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K Number
K970163
Device Name
ALPHA MX (20)/ULTRA PC (30)
Manufacturer
TECHNICAL MEDICAL PRODUCTS, INC.
Date Cleared
1997-12-10

(328 days)

Product Code
BSZ
Regulation Number
868.5160
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This anagelsia gas machine is to be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.

Device Description

Not Found

AI/ML Overview

This document, K970163, is a 510(k) premarket notification letter from the FDA regarding the "Model 20 Alpha MX Gas Machine for Analgesia and Model 30 Ultra PC Gas Machine for Analgesia". This type of document determines substantial equivalence to a predicate device, allowing the device to be marketed. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

Specifically, the document states:

  • "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
  • "This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

Therefore, I cannot provide the requested information because the provided text does not contain a description of acceptance criteria, a study, or the details of a study's methodology as specified in your request. This document is a regulatory approval letter based on substantial equivalence, not a clinical or performance study report.

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).