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510(k) K820943

SYSTEM I INFANT MONITORING SYS by Burr Engineering & Development Co. — Product Code FLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1982
Date Received
April 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Apnea, Facility Use
Device Class
Class II
Regulation Number
868.2377
Review Panel
AN
Submission Type

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