← Product Code [DQK](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK) · K952969

# EIDOS 5003 HOLTER SYSTEM (K952969)

_New Product Development, Inc. · DQK · Jul 16, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K952969

## Device Facts

- **Applicant:** New Product Development, Inc.
- **Product Code:** [DQK](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK.md)
- **Decision Date:** Jul 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1425
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K952969](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K952969)

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