21 C.F.R. · Food and Drugs
21 C.F.R. § 870.1220

Electrode recording catheter or electrode recording probe.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 870.1220 — Electrode recording catheter or electrode recording probe.

§ 870.1220 Electrode recording catheter or electrode recording probe. (a) Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations. (b) Classification. Class II (performance standards).

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 870.1220
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The regulatory text of 21 C.F.R. § 870.1220 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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