Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1875](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1875) → OCR — Lung Sound Monitor

# OCR · Lung Sound Monitor

_Cardiovascular · 21 CFR 870.1875 · Class 2_

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

## Overview

- **Product Code:** OCR
- **Device Name:** Lung Sound Monitor
- **Regulation:** [21 CFR 870.1875](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1875)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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.

## Classification Rationale

Manual stethoscope: Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. Electronic stethoscope: 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.

## 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.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K091732](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OCR/K091732.md) | VRLXP, MODEL XP | Deep Breeze , Ltd. | Mar 4, 2010 | SESE |
| [K073582](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OCR/K073582.md) | VRIICU SYSTEM | Deep Breeze , Ltd. | Oct 15, 2008 | SESE |
| [K061495](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OCR/K061495.md) | VR LUNG ELECTROSONOGRAPH | Deep Breeze , Ltd. | Jul 18, 2007 | SESE |

## Top Applicants

- Deep Breeze , Ltd. — 3 clearances

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

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