FDA-Device2015-04-08Class II

Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.

Leonhard Lang Medizintechnik GmbH
Hazard

The electrodes may fail to transmit signals.

Sold states
Distributed to FL.
Affected count
364,800
Manufactured in
Archenweg 56, N/A, Innsbruck, N/A, Austria
Products
Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1350-2015

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