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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K851658
Device Name CAPNOMED
Applicant
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Applicant Contact EDWARD T GRIFFITH
Correspondent
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Correspondent Contact EDWARD T GRIFFITH
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/23/1985
Decision Date 05/23/1985
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
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