← Product Code [FOH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH) · K954216

# OLYMPIC WARM-BASSINET (K954216)

_Olympic Medical Corp. · FOH · Dec 8, 1995 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH/K954216

## Device Facts

- **Applicant:** Olympic Medical Corp.
- **Product Code:** [FOH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH.md)
- **Decision Date:** Dec 8, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5560
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of suitable size, filled with water which can be heated or in some cases cooled. The device includes electrical heating and water circulating components, and an optional cooling component. The temperature control may be manual or automatic.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH/K954216](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH/K954216)

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