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FDA 510(k)

CADD-MS 3 AMBULATORY INFUSION PUMP

K-Number: K051568 · 2005-11-17

ApplicantSmiths Medical MD, Inc.
Decision Date2005-11-17
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD-MS 3 AMBULATORY INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical MD, Inc.. It received FDA 510(k) clearance on 2005-11-17 under 510(k) number K051568. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADD-MS 3 AMBULATORY INFUSION PUMP?

CADD-MS 3 AMBULATORY INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2005-11-17. The listed applicant is Smiths Medical MD, Inc.. The 510(k) number is K051568.

When did CADD-MS 3 AMBULATORY INFUSION PUMP receive FDA 510(k) clearance?

CADD-MS 3 AMBULATORY INFUSION PUMP received FDA 510(k) clearance on 2005-11-17, under 510(k) number K051568.

Who is the listed applicant for CADD-MS 3 AMBULATORY INFUSION PUMP?

The FDA 510(k) record lists Smiths Medical MD, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CADD-MS 3 AMBULATORY INFUSION PUMP?

The FDA product code for CADD-MS 3 AMBULATORY INFUSION PUMP is FRN.

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Other records listing Smiths Medical MD, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112407SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERSK111386MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)K101180GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,K091181LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPSK082783CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CAREK081156CADD MEDICATION CASSETTE RESERVOIR

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Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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