← Product Code [MWI](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI) · K081552

# SKYLINE 55 (K081552)

_Larsen & Toubro Limited · MWI · Jul 31, 2008 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI/K081552

## Device Facts

- **Applicant:** Larsen & Toubro Limited
- **Product Code:** [MWI](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI.md)
- **Decision Date:** Jul 31, 2008
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2300
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** 3rd-Party Reviewed

## Regulatory Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI/K081552](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI/K081552)

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