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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 K942113
Device Name CARBON DIOXIDE ANALYZER (MODEL CD-3A)
Applicant
AMETEK, INC.
150 FREEPORT RD.
PITTSBURGH,  PA  15238
Applicant Contact JAMES B GILLIKIN
Correspondent
AMETEK, INC.
150 FREEPORT RD.
PITTSBURGH,  PA  15238
Correspondent Contact JAMES B GILLIKIN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/02/1994
Decision Date 02/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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