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 Electrocardiograph
510(k) Number K810988
Device Name IBM 5885 DIGITAL ECG ACQUISITION CART
Applicant
Intl. Business Machines
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Intl. Business Machines
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/13/1981
Decision Date 05/01/1981
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
-
-