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, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K912188
Device Name DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Applicant Contact ANNETTE M HILLRING
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Correspondent Contact ANNETTE M HILLRING
Regulation Number870.1025
Classification Product Code
MHX  
Date Received05/17/1991
Decision Date 12/04/1991
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
-
-