• 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 Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K982215
Device Name MANUAL RESUSCITATOR WITH ACE
Applicant
MEDICAL MARKETING CONCEPTS
P.O. BOX 4341
CROFTON,  MD  21114 -4341
Applicant Contact E J SMITH
Correspondent
MEDICAL MARKETING CONCEPTS
P.O. BOX 4341
CROFTON,  MD  21114 -4341
Correspondent Contact E J SMITH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/23/1998
Decision Date 09/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-