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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Bed Patient
510(k) Number K943481
Device Name INFORMER PLUS
Applicant
Micro-Tech Medical, Inc.
107 Burnside Ave.
East Hartford,  CT  06108
Applicant Contact KEITH CHARLES
Correspondent
Micro-Tech Medical, Inc.
107 Burnside Ave.
East Hartford,  CT  06108
Correspondent Contact KEITH CHARLES
Regulation Number880.2400
Classification Product Code
KMI  
Date Received07/19/1994
Decision Date 11/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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