← Product Code [DQD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD) · K831763

# MAX I (K831763)

_Trade Max, Inc. · DQD · Jan 27, 1984 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K831763

## Device Facts

- **Applicant:** Trade Max, Inc.
- **Product Code:** [DQD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD.md)
- **Decision Date:** Jan 27, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1875
- **Device Class:** Class 2
- **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/DQD/K831763](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K831763)

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