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510(k) Data Aggregation
K Number
K041007Device Name
MILLENIUM, MODELS 2000, 2001 AND 2002
Manufacturer
HYPERBARIC FOR LIFE LLC
Date Cleared
2004-11-15
(210 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
HYPERBARIC FOR LIFE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The conditions listed as appropriate for the use of Hyperbaric Oxygen Therapy in the current The conditions instou as upprophato sic and Medical Society (UHMS)Hyperbaric Oxygen Therapy Committee Report (1998) are as follows: Air or gas embolism; Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; Clostridial myositis and myonecrosis; Crush injury, compartment syndrome, and other acute traumatic ischemias; Decompression sickness; Enhanced healing of selected problem wounds; Exceptional blood loss anemia; Necrotizing soft tissue infections; Osteomyelitis (refractory); Delayed radiation injury ( soft tissue and bone necrosis); Skin grafts and flaps (compromised); Thermal burns; Intracranial abscess.
Device Description
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