FDA 510(k)

MODEL 4242 TELE SYST ARRHYTHMIA MONITOR

K-Number: K822955 · 1982-11-01

Decision Date1982-11-01

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 4242 TELE SYST ARRHYTHMIA MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1982-11-01 under 510(k) number K822955. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 4242 TELE SYST ARRHYTHMIA MONITOR?

MODEL 4242 TELE SYST ARRHYTHMIA MONITOR is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Medtronic Vascular. The 510(k) number is K822955.

When did MODEL 4242 TELE SYST ARRHYTHMIA MONITOR receive FDA 510(k) clearance?

MODEL 4242 TELE SYST ARRHYTHMIA MONITOR received FDA 510(k) clearance on 1982-11-01, under 510(k) number K822955.

Who is the listed applicant for MODEL 4242 TELE SYST ARRHYTHMIA MONITOR?

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

What is the FDA product code for MODEL 4242 TELE SYST ARRHYTHMIA MONITOR?

The FDA product code for MODEL 4242 TELE SYST ARRHYTHMIA MONITOR is DXH. This falls under the Hematology category.

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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.