MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS

• K Number: K002795
• Device Name: MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
• Manufacturer: HYPERTEC, INC.
• Date Cleared: 2000-12-06 ( 90 days)
• Product Code: CBF
• Regulation Number: 868.5470
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 868.5470 Hyperbaric chamber.

(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).