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510(k) K823449

RESPIRATORY GAS ANALYZER by Thoratec Laboratories Corp. — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1983
Date Received
November 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type

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  • K833714 — RESPIRATORY ASSESSMENT SYSTEM (December 29, 1983)
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  • K823287 — RESPIRATORY CIRCUIT ADAPTOR (December 9, 1982)
  • K822769 — THORATEC GAS SAMPLING CONNECTOR (October 6, 1982)
  • K780247 — IMPCO DISPOSABLE AORTIC PUNCH (February 27, 1978)

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