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FDA 510(k)

HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP

K-Number: K033054 · 2003-12-16

ApplicantHarvard Clinical Technology
Decision Date2003-12-16
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Harvard Clinical Technology. It received FDA 510(k) clearance on 2003-12-16 under 510(k) number K033054. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP?

HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP is a medical device that received FDA 510(k) clearance on 2003-12-16. The listed applicant is Harvard Clinical Technology. The 510(k) number is K033054.

When did HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP receive FDA 510(k) clearance?

HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP received FDA 510(k) clearance on 2003-12-16, under 510(k) number K033054.

Who is the listed applicant for HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP?

The FDA 510(k) record lists Harvard Clinical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP?

The FDA product code for HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP is MEA.

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Other records listing Harvard Clinical Technology 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.

K050107HARVARD 2 SYRINGE PUMP, MODEL 2001-001

Related Devices (Code: MEA)

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.

K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc.K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)Smiths Medical Ads, Inc.K143612LifeCare PCA Infusion SystemHospira, Inc.K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0Smiths Medical Asd, Inc.K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMB.Braun Medical, Inc.K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORSmiths Medical MD, 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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