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FDA 510(k)

MODEL 4815 ADAPTER

K-Number: K002496 · 2000-10-10

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

Device Summary

MODEL 4815 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 K002496. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 4815 ADAPTER?

MODEL 4815 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 K002496.

When did MODEL 4815 ADAPTER receive FDA 510(k) clearance?

MODEL 4815 ADAPTER received FDA 510(k) clearance on 2000-10-10, under 510(k) number K002496.

Who is the listed applicant for MODEL 4815 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 4815 ADAPTER?

The FDA product code for MODEL 4815 ADAPTER is DTN.

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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, 5265VK002497MODEL 4810 ANALYZER OUTPUT ADAPTERK001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528K925143MODEL 4800 ACCUPACE PACING SYSTEM ANALYER

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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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