← Product Code [FMZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ) · K001242

# ISOLETTE INFANT INCUBATOR, MODEL C2HS (K001242)

_Hill-Rom Air-Shields · FMZ · Jul 13, 2000 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K001242

## Device Facts

- **Applicant:** Hill-Rom Air-Shields
- **Product Code:** [FMZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ.md)
- **Decision Date:** Jul 13, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5400
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K001242](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K001242)

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