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 Amplifier And Signal Conditioner, Transducer Signal
510(k) Number K913875
Device Name BARD(R) BIOPOTENTIAL AMPLIFIER II
Applicant
Bard Electrophysiology
200 Ames Pond Dr.
Tewksbury,  MA  01876
Applicant Contact MATTHEW NOWLAND
Correspondent
Bard Electrophysiology
200 Ames Pond Dr.
Tewksbury,  MA  01876
Correspondent Contact MATTHEW NOWLAND
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received08/29/1991
Decision Date 11/27/1991
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
-
-