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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K880981
Device Name A2J MZ 44 B TYPE
Applicant
A2j, Inc.
10500 Richmond Suite 201
Houston,  TX  77042
Applicant Contact ZIMMER
Correspondent
A2j, Inc.
10500 Richmond Suite 201
Houston,  TX  77042
Correspondent Contact ZIMMER
Regulation Number892.5780
Classification Product Code
IWE  
Date Received03/08/1988
Decision Date 04/22/1988
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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