← Product Code [LDE](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE) · K944337

# VARIOUS STETHOSCOPES (K944337)

_Rud Riester GmbH & CO KG · LDE · Nov 30, 1994 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K944337

## Device Facts

- **Applicant:** Rud Riester GmbH & CO KG
- **Product Code:** [LDE](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE.md)
- **Decision Date:** Nov 30, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1875
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Regulatory Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K944337](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K944337)

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