← Product Code [DPW](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW) · K875179

# MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A (K875179)

_Tsi, Inc. · DPW · Sep 19, 1988 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K875179

## Device Facts

- **Applicant:** Tsi, Inc.
- **Product Code:** [DPW](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW.md)
- **Decision Date:** Sep 19, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2100
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K875179](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPW/K875179)

**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