← Product Code [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK) · K961687

# EVITA 4 (K961687)

_Drager, Inc. · CBK · Dec 13, 1996 · Anesthesiology · ST_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K961687

## Device Facts

- **Applicant:** Drager, Inc.
- **Product Code:** [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK.md)
- **Decision Date:** Dec 13, 1996
- **Decision:** ST
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5895
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology
- **Attributes:** Therapeutic

## Device Story

Evita 4 is a continuous ventilator providing respiratory support to patients. Device delivers controlled or assisted ventilation; monitors respiratory parameters; integrates capnography functionality. Used in clinical settings (ICU/hospital) by trained healthcare professionals. Output includes ventilation parameters, waveforms, and gas monitoring data displayed on integrated screen. Assists clinicians in managing patient respiratory status; provides life support through mechanical ventilation.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Continuous ventilator; microprocessor-controlled; integrated gas monitoring; digital display; pneumatic and electronic components; standard hospital power source.

## Regulatory Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

## Predicate Devices

- Drager Evita 1 ([K924930](/device/K924930.md))
- Drager Capnosat ([K922849](/device/K922849.md))
- Siemens Servo 300 ([K902859](/device/K902859.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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{0}

Drager Inc.
K961687
Dec. 13, 1996

# 2. SUMMARY AND CERIFICATION

## 2.1 Identification

Applicants Name and Address: Drager Inc.
Critical Care Systems
4101-100 Pleasant Valley Rd.
Chantilly, Virginia 22021
phone: (703) 817 0100
fax: (703) 817 0101

Contact Person: Harald Kneuer
Regulatory Affairs Manager
phone: (703) 817 0100
fax: (703) 817 0101

Manufacturers Address: Dragerwerk AG
Moislinger Allee 53-55
23542 Luebeck
Germany

Date of Application: April 24, 1996

Device Name: Evita 4

Registration Number: Owner/Operator ID No. Drager Inc.: 24 31 188
Registration No. Dragerwerk AG: 96 11 500

## Classification:

|  Classification: | Class II  |
| --- | --- |
|  Panel: | 73  |
|  Code: | CBK  |
|  Classification Name: | Ventilator, Continuous  |
|  Device Listing #: | A911151  |

## Predicate Device(s):

- Drager Evita 1, 510(k) Number: K92 49 30
- Drager Capnosat, 510(k) Number: K92 28 49
- Siemens Servo 300, 510(k) Number: K90 28 59

Drager EVITA 4 Premarket Notification Submission, 510(k)
715
00006

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K961687](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K961687)

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