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K Number
K030713
Device Name
BAY AREA HYPERSCIENCES
Manufacturer
BAY AREA HYPERSCIENCES, LLC
Date Cleared
2003-12-19

(288 days)

Product Code
CBF
Regulation Number
868.5470
Type
Abbreviated
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Air or gas embolism
    1. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
    1. Clostridial myositis and myonecrosis
    1. Crush injury, compartment syndrome or other acute traumatic ischemias
    1. Decompression sickness
    1. Enhanced healing of selected problem wounds
    1. Exceptional blood loss anemia
    1. Necrotizing soft tissue infections
    1. Osteomyelitis (refractory)
    1. Delaved radiation injury (soft tissue and bone necrosis)
    1. Skin grafts and flaps (compromised)
    1. Thermal burns
    1. Intracranial abscesses
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a hyperbaric chamber. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a direct performance study against specific acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the given text.

§ 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).