← Product Code [DTC](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC) · K910223

# CPI MODEL 2215/SEAMED MODEL 3400 (K910223)

_Seamed Corp. · DTC · Mar 19, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K910223

## Device Facts

- **Applicant:** Seamed Corp.
- **Product Code:** [DTC](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC.md)
- **Decision Date:** Mar 19, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3630
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K910223](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K910223)

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