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
510(k) Number K972255
Device Name PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
Applicant
PULSE BIOMEDICAL, INC.
935 SOUTH TROOPER RD.
NORRISTOWN,  PA  19403
Applicant Contact SALEEM HASAN
Correspondent
PULSE BIOMEDICAL, INC.
935 SOUTH TROOPER RD.
NORRISTOWN,  PA  19403
Correspondent Contact SALEEM HASAN
Classification Product Code
LOS
Date Received06/17/1997
Decision Date 07/07/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-