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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, oxygen-uptake
510(k) Number K833714
Device Name RESPIRATORY ASSESSMENT SYSTEM
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 Number868.1730
Classification Product Code
BZL  
Date Received10/21/1983
Decision Date 12/29/1983
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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