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FDA 510(k) Application Details - K052751
Device Classification Name
Accessory To Continuous Ventilator (Respirator)
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
MARK OFORI-KYEI
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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