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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K010093
Device Name NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
Applicant
Drager Medizintechnik GmbH
3136 Quarry Rd.
Telford,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
Drager Medizintechnik GmbH
3136 Quarry Rd.
Telford,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/11/2001
Decision Date 06/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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