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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K971923
Device Name DRAGER-VAPOR 2000
Applicant
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.5880
Classification Product Code
CAD  
Date Received05/23/1997
Decision Date 09/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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