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FDA 510(k), K091505, COR12+
FDA 510(k), K091505, COR12+
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510(K) Number: K091505
Device Name: COR12+
Manufacturer: VIASYS HEALTHCARE GMBH
Device Classification Name: recorder, magnetic tape, medical
Regulation Number: 870.2800
Classification Product Code: DSH
Date Received: 05/21/2009
Decision Date: 06/10/2009
Regulation Medical Specialty: Cardiovascular
Device Name: COR12+
Manufacturer: VIASYS HEALTHCARE GMBH
Device Classification Name: recorder, magnetic tape, medical
Regulation Number: 870.2800
Classification Product Code: DSH
Date Received: 05/21/2009
Decision Date: 06/10/2009
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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