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510(k) K080375

RMX PHYSIOLOGICAL DATA RECORDER by S.L.P. , Ltd. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2008
Date Received
February 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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