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FDA 510(k), K042095, MAMMOTEST
FDA 510(k), K042095, MAMMOTEST
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510(K) Number: K042095
Device Name: MAMMOTEST
Manufacturer: ROBERT G SCHUEPPERT
Device Classification Name: System, X-Ray, Mammographic
Regulation Number: IZH
Classification Product Code: KXA
Date Received: 08/03/2004
Decision Date: 10/29/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: MAMMOTEST
Manufacturer: ROBERT G SCHUEPPERT
Device Classification Name: System, X-Ray, Mammographic
Regulation Number: IZH
Classification Product Code: KXA
Date Received: 08/03/2004
Decision Date: 10/29/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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