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FDA 510(k) Application Details - K030611
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K030611
Device Name
Ventilatory Effort Recorder
Applicant
NELLCOR PURITAN BENNETT (MELVILLE) LTD.
400-303 TERRY FOX DR.
KANATA, ONTARIO K2K 3J1 CA
Other 510(k) Applications for this Company
Contact
Rob Matheson
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
02/26/2003
Decision Date
03/24/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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