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510(k) Data Aggregation
K Number
K040145Device Name
ATA HCM MONOPLACE HYPERBARIC SYSTEM
Manufacturer
Date Cleared
2005-05-04
(468 days)
Product Code
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
ATA HYPERBARIC CHAMBER MANUFACTURING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The conditions listed as appropriate for the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
- Air or Gas Embolism .
Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning
- Clostridial Myositis and Myonecrosis (Gas Gangrene) .
- Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias ◀
- Decompression Sickness ◆
- Enhancement of Healing in Selected Problem Wounds .
- Exceptional Blood Loss (Anemia) .
- . Intracranial Abscess
- Necrotizing Soft Tissue Infections .
- Osteomyelitis (Refractory) .
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis) ◆
- Skin Grafts and Flaps (Compromised) .
- Thermal Burns .
Device Description
Monoplace Hyperbaric Chamber
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