(226 days)
Not Found
Not Found
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The text is a summary and certification for a medical device (ventilator) and does not contain details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. It primarily lists administrative and classification information about the device.
{0}------------------------------------------------
SUMMARY AND CERIFICATION 2.
Drager Inc. K96168 Dec. 13, 1996
Identification 2.1
Applicants Name and Address: Drager Inc. Critical Care Systems 4101-100 Pleasant Valley Rd. Chantilly, Virginia 22021 (703) 817 0100 phone: fax: (703) 817 0101
Contact Person:
Harald Kneuer Regulatory Affairs Manager (703) 817 0100 phone: (703) 817 0101 fax:
Manufacturers Address:
Dragerwerk AG Moislinger Allee 53-55 23542 Luebeck Germany
Date of Application:
Device Name:
Evita 4
April 24, 1996
Registration Number:
Owner/Operator ID No. Drager Inc .: 24 31 188 Registration No. Dragerwerk AG:
96 11 500
Classification:
Classification: Panel: Code: Classification Name: Device Listing #:
Class II
73
CBK
Ventilator, Continuous
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)
00000
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).