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 system, imaging, pulsed echo, ultrasonic
510(k) Number K953673
Device Name ECLIPSE PROBE COVER
Applicant
PARKER LABORATORIES, INC.
307 WASHINGTON ST.
ORANGE,  NJ  07050
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
PARKER LABORATORIES, INC.
307 WASHINGTON ST.
ORANGE,  NJ  07050
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/07/1995
Decision Date 03/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-