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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 K930524
Device Name END TIDAL CO2 OPTION B
Applicant
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Applicant Contact JIM ROOKS
Correspondent
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Correspondent Contact JIM ROOKS
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/02/1993
Decision Date 02/07/1994
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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