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 Detector And Alarm, Arrhythmia
510(k) Number K955023
Device Name BRENTWOOD PC-ECG
Applicant
Brentwood Medical Products, Inc.
3555 Lomita Blvd. Suite E
Torrance,  CA  90505
Applicant Contact CHANDU PATIL
Correspondent
Brentwood Medical Products, Inc.
3555 Lomita Blvd. Suite E
Torrance,  CA  90505
Correspondent Contact CHANDU PATIL
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/02/1995
Decision Date 01/22/1997
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
Recalls CDRH Recalls
-
-