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 Transducer, Blood-Pressure, Extravascular
510(k) Number K851989
Device Name DOME, DISPOSABLE, STERILE
Applicant
Transamerica Delaval, Inc.
325 Halstead St.
P.O. Bin 7087
Pasadena,  CA  91109
Applicant Contact RICHARD G EKSTROM
Correspondent
Transamerica Delaval, Inc.
325 Halstead St.
P.O. Bin 7087
Pasadena,  CA  91109
Correspondent Contact RICHARD G EKSTROM
Regulation Number870.2850
Classification Product Code
DRS  
Date Received05/07/1985
Decision Date 08/19/1985
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
-
-