← Product Code [JOM](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM) · K213730

# MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (K213730)

_Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · JOM · Apr 21, 2022 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K213730

## Device Facts

- **Applicant:** Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
- **Product Code:** [JOM](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM.md)
- **Decision Date:** Apr 21, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2780
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K213730](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOM/K213730)

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