FDA 510(k) Application Details - K230931

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K230931
Device Name Gas-Machine, Anesthesia
Applicant DrΣgerwerk AG Co. KGaA
Moislinger Allee 53-55
Lⁿbeck 23542 DE
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Contact Marianne Selent
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 04/03/2023
Decision Date 07/23/2023
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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