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510(k) K003499

REMVIEW SLEEP RECORDER, MODEL 320 by Respironics, Inc. — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2001
Date Received
November 13, 2000
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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