← Product Code [DWJ](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ) · K964377

# THERMAL REGULATION SYSTEM                                       BLANKET (K964377)

_Gibeck, Inc. · DWJ · Apr 23, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K964377

## Device Facts

- **Applicant:** Gibeck, Inc.
- **Product Code:** [DWJ](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ.md)
- **Decision Date:** Apr 23, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5900
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K964377](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K964377)

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