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, Biopotential
510(k) Number K910307
Device Name CARDIOLAB AMPLIFIER MODULE (CAM)
Applicant
Prucka Engineering, Inc.
8030 El Rio
Houston,  TX  77054
Applicant Contact MATTHEW W PRUCKA
Correspondent
Prucka Engineering, Inc.
8030 El Rio
Houston,  TX  77054
Correspondent Contact MATTHEW W PRUCKA
Regulation Number870.2050
Classification Product Code
DRR  
Date Received01/24/1991
Decision Date 04/12/1991
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
-
-