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FDA 510(k), K133532, ALARIS SYSTEM WITH GUARDRAILS SUITE MX
FDA 510(k), K133532, ALARIS SYSTEM WITH GUARDRAILS SUITE MX
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510(K) Number: K133532
Device Name: ALARIS SYSTEM WITH GUARDRAILS SUITE MX
Manufacturer: CHRISTINE CATON
Device Classification Name: Pump, Infusion
Regulation Number: FRN
Classification Product Code: KXA
Date Received: 11/18/2013
Decision Date: 08/21/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: ALARIS SYSTEM WITH GUARDRAILS SUITE MX
Manufacturer: CHRISTINE CATON
Device Classification Name: Pump, Infusion
Regulation Number: FRN
Classification Product Code: KXA
Date Received: 11/18/2013
Decision Date: 08/21/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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