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510(k) K050006

BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO by C.R. Bard, Inc. — Product Code DRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2005
Date Received
January 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Transducer Signal
Device Class
Class II
Regulation Number
870.2060
Review Panel
CV
Submission Type

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