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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 K934344
Device Name HOME AMB-ALERT
Applicant
Medway
2176 Hillsboro Rd.
Suite 120-362
Franklin,  TN  37064
Applicant Contact JAMES J CALLAWAY
Correspondent
Medway
2176 Hillsboro Rd.
Suite 120-362
Franklin,  TN  37064
Correspondent Contact JAMES J CALLAWAY
Regulation Number880.2400
Classification Product Code
KMI  
Date Received09/08/1993
Decision Date 04/29/1994
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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