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510(k) K042745

LIFESCREEN APNEA by Del Mar Reynolds Medical, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2005
Date Received
October 4, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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