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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, Oxygen, Gaseous-Phase
510(k) Number K823449
Device Name RESPIRATORY GAS ANALYZER
Applicant
THORATEC LABORATORIES CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
THORATEC LABORATORIES CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1720
Classification Product Code
CCL  
Date Received11/12/1982
Decision Date 01/05/1983
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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