← Product Code [DTY](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY) · K902654

# CDI (TM) SYSTEM 100 MONITORING SYSTEM (K902654)

_3M Health Care, Ltd. · DTY · Nov 5, 1990 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K902654

## Device Facts

- **Applicant:** 3M Health Care, Ltd.
- **Product Code:** [DTY](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY.md)
- **Decision Date:** Nov 5, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4410
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K902654](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTY/K902654)

**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