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FDA 510(k) Application Details - K222331
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K222331
Device Name
Ventilatory Effort Recorder
Applicant
Itamar Medical, Ltd
9 Halamish Street
Casearea 3088900 IL
Other 510(k) Applications for this Company
Contact
Efrat Litman
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
08/02/2022
Decision Date
09/14/2022
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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