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FDA 510(k)

CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP

K-Number: K955180 · 1996-05-23

ApplicantSims Deltec, Inc.
Decision Date1996-05-23
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1996-05-23 under 510(k) number K955180. 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-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP?

CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1996-05-23. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K955180.

When did CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP receive FDA 510(k) clearance?

CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP received FDA 510(k) clearance on 1996-05-23, under 510(k) number K955180.

Who is the listed applicant for CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP?

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

What is the FDA product code for CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP?

The FDA product code for CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP is FRN.

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Other records listing Sims Deltec, 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.

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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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