← Product Code [DXG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG) · K813223

# DISPOSABLE PLASTIC SYRINGE W/NEEDLE (K813223)

_Sam Joo Industrial Co., Ltd. · DXG · Apr 15, 1982 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K813223

## Device Facts

- **Applicant:** Sam Joo Industrial Co., Ltd.
- **Product Code:** [DXG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG.md)
- **Decision Date:** Apr 15, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1435
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K813223](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K813223)

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