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FDA 510(k), K050055, GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
FDA 510(k), K050055, GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
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510(K) Number: K050055
Device Name: GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
Manufacturer: DAN KOSEDNAR
Device Classification Name: Gas-Machine, Anesthesia
Regulation Number: BSZ
Classification Product Code: KXA
Date Received: 01/11/2005
Decision Date: 02/04/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
Manufacturer: DAN KOSEDNAR
Device Classification Name: Gas-Machine, Anesthesia
Regulation Number: BSZ
Classification Product Code: KXA
Date Received: 01/11/2005
Decision Date: 02/04/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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