Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1230](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1230) → NMB — Catheter, Oximeter, Fiber Optic, Reprocessed

# NMB · Catheter, Oximeter, Fiber Optic, Reprocessed

_Cardiovascular · 21 CFR 870.1230 · Class 2_

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

## Overview

- **Product Code:** NMB
- **Device Name:** Catheter, Oximeter, Fiber Optic, Reprocessed
- **Regulation:** [21 CFR 870.1230](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1230)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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