← Product Code [DXM](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM) · K791892

# TAPE-A-TRACE (K791892)

_Instromedix, Inc. · DXM · Nov 5, 1979 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM/K791892

## Device Facts

- **Applicant:** Instromedix, Inc.
- **Product Code:** [DXM](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM.md)
- **Decision Date:** Nov 5, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1450
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM/K791892](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM/K791892)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
