FDA 510(k) Application Details - K052751

Device Classification Name Accessory To Continuous Ventilator (Respirator)

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510(K) Number K052751
Device Name Accessory To Continuous Ventilator (Respirator)
Applicant MEDISERVE INFORMATION SYSTEMS, INC.
3225 S. HARDY DR., SUITE 101
TEMPE, AZ 85282 US
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Contact MARK OFORI-KYEI
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Regulation Number 868.5895

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Classification Product Code MOD
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Date Received 09/30/2005
Decision Date 12/23/2005
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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