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FDA 510(k)

MODEL 4810 ANALYZER OUTPUT ADAPTER

K-Number: K002497 · 2000-10-10

ApplicantPace Medical
Decision Date2000-10-10
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 4810 ANALYZER OUTPUT ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 2000-10-10 under 510(k) number K002497. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 4810 ANALYZER OUTPUT ADAPTER?

MODEL 4810 ANALYZER OUTPUT ADAPTER is a medical device that received FDA 510(k) clearance on 2000-10-10. The listed applicant is Pace Medical. The 510(k) number is K002497.

When did MODEL 4810 ANALYZER OUTPUT ADAPTER receive FDA 510(k) clearance?

MODEL 4810 ANALYZER OUTPUT ADAPTER received FDA 510(k) clearance on 2000-10-10, under 510(k) number K002497.

Who is the listed applicant for MODEL 4810 ANALYZER OUTPUT ADAPTER?

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

What is the FDA product code for MODEL 4810 ANALYZER OUTPUT ADAPTER?

The FDA product code for MODEL 4810 ANALYZER OUTPUT ADAPTER is DTC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pace Medical 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.

K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265VK002496MODEL 4815 ADAPTERK001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528K925143MODEL 4800 ACCUPACE PACING SYSTEM ANALYER

View all 19 devices →

Related Devices (Code: DTC)

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.

K170815PSA CableBoston Scientific CorporationK083674PK-141 PATIENT CABLEBiotronik, Inc.K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, Inc.K961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, Inc.K910595MODEL 5311B A-V PACING SYSTEM ANALYZERMedtronic Vascular

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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