EVITA 4

K961687 · Drager, Inc. · CBK · Dec 13, 1996 · Anesthesiology

Device Facts

• Record ID: K961687
• Device Name: EVITA 4
• Applicant: Drager, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 13, 1996
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• 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.

Indications for Use

Indicated for patients requiring continuous mechanical ventilation support.

Regulatory Classification

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)
• Drager Capnosat (K922849)
• Siemens Servo 300 (K902859)

Submission Summary (Full Text)

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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: [phone]
fax: [phone]

Contact Person: Harald Kneuer
Regulatory Affairs Manager
phone: [phone]
fax: [phone]

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