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Model 950-12l Holter Recorder Without Analysis

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102723

by Memtec Corp.

Identifiers

510(k) Number
K102723 FDA 510(k)
FDA Product Code
MWJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2800 FDA 510(k)
Regulation Number
870.2800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Model 950-12l Holter Recorder Without Analysis by Memtec Corp. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Memtec Corp.

Sources (1)

  • FDA 510(k) K102723 24 fields · synced Jun 18, 2026