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FDA 510(k)

AMBIT INTERMITTENT AMBULATORY INFUSION PUMP

K-Number: K033425 · 2003-11-06

ApplicantSorenson Medical, Inc.
Decision Date2003-11-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMBIT INTERMITTENT AMBULATORY INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Sorenson Medical, Inc.. It received FDA 510(k) clearance on 2003-11-06 under 510(k) number K033425. 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 AMBIT INTERMITTENT AMBULATORY INFUSION PUMP?

AMBIT INTERMITTENT AMBULATORY INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2003-11-06. The listed applicant is Sorenson Medical, Inc.. The 510(k) number is K033425.

When did AMBIT INTERMITTENT AMBULATORY INFUSION PUMP receive FDA 510(k) clearance?

AMBIT INTERMITTENT AMBULATORY INFUSION PUMP received FDA 510(k) clearance on 2003-11-06, under 510(k) number K033425.

Who is the listed applicant for AMBIT INTERMITTENT AMBULATORY INFUSION PUMP?

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

What is the FDA product code for AMBIT INTERMITTENT AMBULATORY INFUSION PUMP?

The FDA product code for AMBIT INTERMITTENT AMBULATORY INFUSION PUMP is FRN.

Related Clinical Trials

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.

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Other records listing Sorenson Medical, 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.

K052221AMBIT PUSH & PLAY AMBULATORY INFUSION PUMPK033325AMBIT CONTINUOUS AMBULATORY INFUSION PUMPK002434PALM PUMPK001287EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLK99136330 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU

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

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

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