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FDA 510(k), K121479, AIM
FDA 510(k), K121479, AIM
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510(K) Number: K121479
Device Name: AIM
Manufacturer: CAROLINE GREEN
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: KXA
Date Received: 05/18/2012
Decision Date: 09/13/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: AIM
Manufacturer: CAROLINE GREEN
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: KXA
Date Received: 05/18/2012
Decision Date: 09/13/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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