FDA 510(k) Application Details - K041724

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K041724
Device Name Ventilatory Effort Recorder
Applicant MEDCARE FLAGA
SIDUMULI 24
REYKJAVIK 108 IS
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Contact BERGLIND HALLGRIMSDOTTIR
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 06/24/2004
Decision Date 09/28/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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