← Product Code [MWJ](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ) · K100310

# BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS (K100310)

_BTL Industries, Inc. · MWJ · Oct 13, 2010 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K100310

## Device Facts

- **Applicant:** BTL Industries, Inc.
- **Product Code:** [MWJ](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ.md)
- **Decision Date:** Oct 13, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2800
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K100310](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWJ/K100310)

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