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 Antiserum, Positive Control, Aspergillus Spp.
510(k) Number K904499
Device Name NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
Applicant
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Applicant Contact BERNARD ACKERMAN
Correspondent
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Correspondent Contact BERNARD ACKERMAN
Regulation Number866.3040
Classification Product Code
KFG  
Date Received10/01/1990
Decision Date 07/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-