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510(k) Data Aggregation
K Number
K030713Device Name
BAY AREA HYPERSCIENCES
Manufacturer
Date Cleared
2003-12-19
(288 days)
Product Code
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
BAY AREA HYPERSCIENCES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- 1. Air or gas embolism
- 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
- 3. Clostridial myositis and myonecrosis
- 4. Crush injury, compartment syndrome or other acute traumatic ischemias
- 5. Decompression sickness
- 6. Enhanced healing of selected problem wounds
- 7. Exceptional blood loss anemia
- 8. Necrotizing soft tissue infections
- 9. Osteomyelitis (refractory)
- 10. Delaved radiation injury (soft tissue and bone necrosis)
- 11. Skin grafts and flaps (compromised)
- 12. Thermal burns
- 13. Intracranial abscesses
Device Description
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