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510(k) Premarket Notification
510(k | Registration | Adverse | Recall | PM | Classification | Standards
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CFR Title | Radiation-Emitting | X-Ray | Medsun | CLIA
21 Products Assembler Reports

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Device Classification Name system, x-ray, tomography, computed

510(k) Number K940606

Device Name HISPEED ADVANTAGE II

GE MEDICAL SYSTEMS

p.o. box 414

Applicant
milwaukee,
53201

Contact larry a kroger

Regulation Number 892.1750

Classification Product Code JAK

Date Received 02/10/1994

Decision Date 08/23/1994

Decision substantially equivalent (SE)

Classification Advisory Committee Radiology

Review Advisory Committee Radiology

Statement/Summary/Purged Status Summary/purged 510(k)

Type Traditional

Reviewed by Third Party No

 Expedited Review

 
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Page Last Updated: 05/05/2010

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