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510(k) K810828

NON-INVASIVE AMPLIFIER by Henry Ford Hospital — Product Code DRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1981
Date Received
March 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Biopotential
Device Class
Class II
Regulation Number
870.2050
Review Panel
CV
Submission Type

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