Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1120](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1120) → JED — Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

# JED · Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

_Anesthesiology · 21 CFR 868.1120 · Class 3_

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

## Overview

- **Product Code:** JED
- **Device Name:** Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
- **Regulation:** [21 CFR 868.1120](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1120)
- **Device Class:** 3
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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