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FDA 510(k) Application Details - K033402
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K033402
Device Name
Ventilatory Effort Recorder
Applicant
PRO-TECH SERVICES, INC.
4338 HARBOUR POINTE BLVD. S.W.
MUKILTEO, WA 98275 US
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Contact
NEIL SHELLER
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
MNR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2003
Decision Date
06/30/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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