# Patient Health Software - 1.0 (BK060035)

_MAK-System · May 9, 2007 · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/BK060035

## Device Facts

- **Applicant:** MAK-System
- **Decision Date:** May 9, 2007
- **Decision:** SESE

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**Source:** [https://fda-staging.innolitics.com/device/BK060035](https://fda-staging.innolitics.com/device/BK060035)

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