• 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 Cpr Aid Device Without Feedback
510(k) Number K944667
Device Name LIFE PULSE TESUSCITATION TIMER
Applicant
Green Field Medical Sourcing, Inc.
910 Boston Tpke. Rd.
Shrewsbury,  MA  01545
Applicant Contact DONALD R GORSUCH
Correspondent
Green Field Medical Sourcing, Inc.
910 Boston Tpke. Rd.
Shrewsbury,  MA  01545
Correspondent Contact DONALD R GORSUCH
Regulation Number870.5210
Classification Product Code
PMK  
Date Received09/20/1994
Decision Date 10/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-