21 CFR 870.2800 — Recorder, Magnetic Tape, Medical
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2800
Identification
A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 2 | 194 | 3rd Party |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | 32 | |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | 59 | |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 2 | 23 | Implant |
