Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Monitor, Bed Patient
510(k) Number K911079
Device Name 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 Received03/11/1991
Decision Date 09/13/1991
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
-
-