← Product Code [DSF](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF) · K800851

# SERIES 602 CKGTM RECORDER (K800851)

_Cardio Kinetics, Inc. · DSF · Apr 24, 1980 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K800851

## Device Facts

- **Applicant:** Cardio Kinetics, Inc.
- **Product Code:** [DSF](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF.md)
- **Decision Date:** Apr 24, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2810
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Regulatory Identification

A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K800851](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K800851)

**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
