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 System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K855127
Device Name AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202
Applicant
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Applicant Contact HANS, P.E.
Correspondent
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Correspondent Contact HANS, P.E.
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/23/1985
Decision Date 08/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-