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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K911348
Device Name RIGID ENDOSCOPE
Applicant
Bruel & Kjaer
18 Naerum Hovedgode
Naerum 2850,  DK
Applicant Contact AAGE RUBY
Correspondent
Bruel & Kjaer
18 Naerum Hovedgode
Naerum 2850,  DK
Correspondent Contact AAGE RUBY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/27/1991
Decision Date 06/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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