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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 K823926
Device Name BED-CHECK: II-IFAC
Applicant
BED-CHECK CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BED-CHECK CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2400
Classification Product Code
KMI  
Date Received12/29/1982
Decision Date 04/18/1983
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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