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 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K941252
Device Name RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR
Applicant
Ansar
242 S. Eighth St.
Philidelphia,  PA  19107
Applicant Contact ROBERT G WELCH
Correspondent
Ansar
242 S. Eighth St.
Philidelphia,  PA  19107
Correspondent Contact ROBERT G WELCH
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/15/1994
Decision Date 09/20/1995
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
-
-